Serplulimab Clinical Trials (2026): 106 Studies for Immunotherapy & Cervical Cancer

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

106 Serplulimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 79 indications (including Immunotherapy & Cervical Cancer) and 10,884 total planned enrollment. 6 Phase 3 Serplulimab trials and 75 Phase 2, 2 Phase 4 are listed. 73 Serplulimab clinical trials are actively recruiting. Most recent activity: NCT06850103 (Dec 2032).

Serplulimab clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingcompletednot yet recruitingunknownTotal
P133
P1/P21337
P233101181375
P2/P31124
P32136
P422
N/A2349

Recruiting Serplulimab clinical trials (73)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT06850103SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With OligometastasesP2Colorectal Carcinoma51Apr 2025
NCT07381400Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)P2Rectal Cancer128Feb 2026
NCT07177443Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal CarcinomaP3Locally Advanced Nasopharyngeal Carcinoma456Sep 2025
NCT07283692Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)P2Triple Negative Breast Cancer46Mar 2026
NCT07527520Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II TrialP2Rectal Cancer165Jun 2026
NCT07466303Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast CancerP2Breast Cancer84Mar 2026
NCT07318883A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung CancerP2/P3Squamous NSCLC720Mar 2026
NCT07141771An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular TypingP1/P2SCLC, Extensive Stage100Dec 2025
NCT07347951A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal CancerP2Locally Advanced Rectal Cancer (LARC)30Dec 2025
NCT06781281NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.Breast Cancer Invasive709Dec 2024
NCT07155122Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the EsophagealP2Small-Cell Carcinoma of the Esophageal15Sep 2025
NCT07134101SMARTi-RC01Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)P2Colorectal Cancer (Diagnosis)138Sep 2025
NCT06580665Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung CancerN/ANon-small Cell Lung Cancer134Sep 2024
NCT07403435Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCCP2Esophageal Squamous Cell Carcinoma (ESCC)22Feb 2026
NCT06860529Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast CancerP2HR+/HER2- Breast Cancer357Apr 2025
NCT07398937ECTOP-1036Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLCP2Resectable Stage II-IIIa Squamous NSCLC116Feb 2026
NCT06692491SPRINGStudy of Precision Treatment for Rare Tumours in China Guided by PDO and NGSP2Rare Tumour200Jan 2025
NCT06280495Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC PatientsP2/P3Colorectal Cancer156Feb 2024
NCT07604909A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant ChemotherapyP2Colorectal Cancer40May 2026
NCT07506057SHIELDTrastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard TherapyP2Urothelial Carcinoma20Jul 2025
NCT07235930Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic CancerP3Non-Resectable Pancreas Carcinoma292Nov 2025
NCT05872685FOCUS-05Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)P2Adenocarcinoma of the Stomach314Dec 2023
NCT05975749Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric CancerP2Gastric Cancer114Jan 2023
NCT07543848A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal CancerP2Rectal Neoplasms20May 2026
NCT07231445Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung CancerP1Small Cell Lung Cancer100Apr 2026
NCT07418866FANLUNG-2:The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung CancerP2NSCLC (Advanced Non-small Cell Lung Cancer)70Feb 2026
NCT07172412Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung CancerP2Extensive Stage Lung Small Cell Cancer165Nov 2025
NCT07277842PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal CancerP3Locally Advanced Low Rectal Adenocarcinoma382Dec 2025
NCT07150949SERRACLong-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)P2Locally Advanced Rectal Cancer138Aug 2025
NCT07358585A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal CancerP1/P2Colon Cancer Adenocarcinoma126Jan 2026
NCT07336953A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)P3PDAC - Pancreatic Ductal Adenocarcinoma198Feb 2026
NCT05742425Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal MetastasesP2Unresectable Colon Cancer Peritoneal Metastases30Mar 2023
NCT07020247Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE StudyP3Locally Advanced Rectal Cancer (LARC)184Nov 2024
NCT07391826Megestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Receiving Neoadjuvant Therapy With Serplulimab Combined With SOXP2Stage III Gastric Cancer48Feb 2026
NCT06461910Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction AdenocarcinomaP2Gastric Cancer30Jun 2024
NCT06295926Serplulimab Combined With CCRT for LS-SCLC.P2Small Cell Lung Cancer96Apr 2024
NCT06716619A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid TumorsP1Tumor Associated Lymph Node T Cell32Feb 2025
NCT07583511Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled StudyP2Small-cell Lung Cancer90Feb 2024
NCT06354218Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old AgeP2Esophageal Carcinoma50Dec 2023
NCT07340489Serplulimab for Locally Advanced Cervical CancerP2Cervical Cancer216Dec 2025
NCT07134218Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal CancerP2/P3Rectal Cancer180Oct 2025
NCT07175389JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment FailureP1/P2Refractory Pancreatic Ductal Adenocarcinoma10Oct 2025
NCT06848699A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid TumorsP1/P2Solid Tumor Cancer105Feb 2025
NCT06554535Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung CancerP2Extensive-Stage Small Cell Lung Cancer43Oct 2024
NCT07064876Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung CancerP2Early Lung Cancer25Oct 2025
NCT06099951Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation TherapyP2Colorectal Cancer53Nov 2023
NCT05954429A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 StudyP2Colorectal Cancer50Jul 2023
NCT06531291Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine DifferentiationP2ESCC80Aug 2024
NCT06521866Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal CancerP2Advanced Colorectal Carcinoma208Mar 2025
NCT06128252Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric CancerN/AGastric Cancer96Sep 2024
NCT06462105Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung CancerN/ASmall Cell Lung Cancer60Jul 2024
NCT07596121Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%P2NSCLC (Non-small Cell Lung Cancer)60May 2026
NCT06388135Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell CarcinomaP4Esophageal Squamous Cell Carcinoma80May 2024
NCT05766800Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung CancerP2Locally Advanced100Mar 2023
NCT07446465FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal CancerP4Colorectal Cancer (Locally Advanced or Metastatic)42Mar 2026
NCT06156332A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard TherapyN/AAdvanced Solid Tumors With Neuroendocrine Differentiation39Jan 2024
NCT06727617Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk FactorsP2Cervical Cancers134Nov 2024
NCT06497530Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLCP2Extensive-Stage Small Cell Lung Cancer30Dec 2024
NCT06542588Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARCP2Rectal Cancer29Jul 2024
NCT06439550Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJCP2HER2-positive Gastric Cancer42Jul 2024
NCT06433869The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant AscitesP2Malignant Ascites60Dec 2023
NCT05957510Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After TreatmentP2Small-cell Lung Cancer66Jul 2023
NCT05731726Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal CancerP2pMMR50Feb 2023
NCT06601309ESCCBiomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCCP2Esophageal Squamous Cell Carcinoma90Jul 2024
NCT07269782A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCP2Non Small Cell Lung Cancer60Jan 2026
NCT05988372SAGESurufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)P2Locally Advanced Pancreatic Cancer50Oct 2023
NCT06576921Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric JunctionP2Stomach Neoplasms116Nov 2024
NCT06491355First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal CancerP2Efficacy, Self72Jul 2024
NCT06911606LS-SCLCStudy of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)P2SCLC, Limited Stage45May 2024
NCT06302062TAL-TPhase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid TumorsP1Advanced Solid Tumor23Jun 2023
NCT06368141NeoCHICNeoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon CancerP2Colon Cancer56May 2024
NCT06455072Nituzumab Plus Serplulimab Combined With SBRT in Cervical CancerP2Cervical Cancer37Feb 2023
NCT06496789Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction CancerP2Gastric Adenocarcinoma35May 2023

Serplulimab clinical trials by indication

Colorectal Cancer (5)

NCTAcronymPhaseStatusTitle
NCT06280495P2/P3recruitingNeoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
NCT07604909P2recruitingA Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy
NCT06099951P2not yet recruitingTotal Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy
NCT05954429P2recruitingA Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
NCT05894837P2unknownSerplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver Metastases

Cervical Cancer (5)

NCTAcronymPhaseStatusTitle
NCT06419673P2active not recruitingSerplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
NCT07340489P2recruitingSerplulimab for Locally Advanced Cervical Cancer
NCT05883670N/AunknownReal-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
NCT05444374P2unknownA Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer
NCT06455072P2recruitingNituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer

Rectal Cancer (4)

NCTAcronymPhaseStatusTitle
NCT07381400P2not yet recruitingNeoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)
NCT07527520P2not yet recruitingNeoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial
NCT07134218P2/P3not yet recruitingNeoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer
NCT06542588P2recruitingShort-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC

Small Cell Lung Cancer (4)

NCTAcronymPhaseStatusTitle
NCT07231445P1recruitingStudy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
NCT06295926P2recruitingSerplulimab Combined With CCRT for LS-SCLC.
NCT06462105N/Anot yet recruitingLiposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer
NCT05882630P1/P2unknownSurufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

Gastric Cancer (3)

NCTAcronymPhaseStatusTitle
NCT05975749P2recruitingAdjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer
NCT06461910P2recruitingEfficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
NCT06128252N/ArecruitingClinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer

Non-small Cell Lung Cancer (3)

NCTAcronymPhaseStatusTitle
NCT06580665N/Anot yet recruitingCryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
NCT05775796ECTOP-1013P2completedEvaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
NCT06195683NSCLCP2unknownSerplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.

Esophageal Squamous Cell Carcinoma (3)

NCTAcronymPhaseStatusTitle
NCT05659251P2active not recruitingSerplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
NCT06388135P4not yet recruitingSerplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
NCT06601309ESCCP2recruitingBiomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Breast Cancer (2)

NCTAcronymPhaseStatusTitle
NCT07466303P2not yet recruitingSerplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer
NCT06394661P2active not recruitingSerplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Locally Advanced Rectal Cancer (LARC) (2)

NCTAcronymPhaseStatusTitle
NCT07347951P2recruitingA Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
NCT07020247P3recruitingPersonalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study

Extensive Stage Lung Small Cell Cancer (2)

NCTAcronymPhaseStatusTitle
NCT07172412P2not yet recruitingOpen-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer
NCT06350162P2unknownTesting the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC

Non-Resectable Pancreas Carcinoma (2)

NCTAcronymPhaseStatusTitle
NCT07235930P3recruitingFirstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer
NCT06393166P2unknownSequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer

Extensive-Stage Small Cell Lung Cancer (2)

NCTAcronymPhaseStatusTitle
NCT06554535P2not yet recruitingEfficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
NCT06497530P2recruitingMaintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC

Small-cell Lung Cancer (2)

NCTAcronymPhaseStatusTitle
NCT07583511P2recruitingTeniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study
NCT05957510P2recruitingSafety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

Malignant Ascites (2)

NCTAcronymPhaseStatusTitle
NCT06433869P2recruitingThe Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
NCT05501340P1/P2unknownPD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

NSCLC (Non-small Cell Lung Cancer) (1)

NCTAcronymPhaseStatusTitle
NCT07596121P2recruitingSerplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%

Rectal Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT07543848P2not yet recruitingA Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer

Squamous NSCLC (1)

NCTAcronymPhaseStatusTitle
NCT07318883P2/P3not yet recruitingA Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

Triple Negative Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07283692P2recruitingNeoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)

Colorectal Cancer (Locally Advanced or Metastatic) (1)

NCTAcronymPhaseStatusTitle
NCT07446465P4not yet recruitingFOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

NSCLC (Advanced Non-small Cell Lung Cancer) (1)

NCTAcronymPhaseStatusTitle
NCT07418866P2not yet recruitingFANLUNG-2:The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung Cancer

PDAC - Pancreatic Ductal Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07336953P3not yet recruitingA Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

Esophageal Squamous Cell Carcinoma (ESCC) (1)

NCTAcronymPhaseStatusTitle
NCT07403435P2not yet recruitingShort-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCC

Stage III Gastric Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07391826P2not yet recruitingMegestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Receiving Neoadjuvant Therapy With Serplulimab Combined With SOX

Resectable Stage II-IIIa Squamous NSCLC (1)

NCTAcronymPhaseStatusTitle
NCT07398937ECTOP-1036P2recruitingComparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC

Colon Cancer Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07358585P1/P2not yet recruitingA Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer

Non Small Cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07269782P2recruitingA Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

SCLC, Extensive Stage (1)

NCTAcronymPhaseStatusTitle
NCT07141771P1/P2not yet recruitingAn Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Locally Advanced Low Rectal Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07277842P3not yet recruitingPD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer

Early Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07064876P2not yet recruitingSerplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer

Refractory Pancreatic Ductal Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07175389P1/P2not yet recruitingJDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure

Locally Advanced Nasopharyngeal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07177443P3not yet recruitingSerplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

Colorectal Cancer (Diagnosis) (1)

NCTAcronymPhaseStatusTitle
NCT07134101SMARTi-RC01P2not yet recruitingNeoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)

Small-Cell Carcinoma of the Esophageal (1)

NCTAcronymPhaseStatusTitle
NCT07155122P2not yet recruitingEfficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal

Locally Advanced Rectal Cancer (1)

NCTAcronymPhaseStatusTitle
NCT07150949SERRACP2recruitingLong-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)

Non-Clear Cell Renal Cell Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07488533P2active not recruitingComparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma

Urothelial Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT07506057SHIELDP2recruitingTrastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy

Colorectal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06850103P2recruitingSCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases

HR+/HER2- Breast Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06860529P2recruitingSerplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Advanced Colorectal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06521866P2recruitingPhase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer

Solid Tumor Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06848699P1/P2recruitingA Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors

Tumor Associated Lymph Node T Cell (1)

NCTAcronymPhaseStatusTitle
NCT06716619P1recruitingA Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors

Gastric Cancer Stage III (1)

NCTAcronymPhaseStatusTitle
NCT07257575P2active not recruitingA Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric Adenocarcinoma

Rare Tumour (1)

NCTAcronymPhaseStatusTitle
NCT06692491SPRINGP2not yet recruitingStudy of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Breast Cancer Invasive (1)

NCTAcronymPhaseStatusTitle
NCT06781281N/ArecruitingNabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

Cervical Cancers (1)

NCTAcronymPhaseStatusTitle
NCT06727617P2recruitingSerplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

Stomach Neoplasms (1)

NCTAcronymPhaseStatusTitle
NCT06576921P2recruitingEfficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction

ESCC (1)

NCTAcronymPhaseStatusTitle
NCT06531291P2not yet recruitingSurufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation

HER2-positive Gastric Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06439550P2not yet recruitingAdjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJC

Efficacy, Self (1)

NCTAcronymPhaseStatusTitle
NCT06491355P2not yet recruitingFirst-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer

SCLC, Limited Stage (1)

NCTAcronymPhaseStatusTitle
NCT06911606LS-SCLCP2recruitingStudy of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)

Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06422858StarsP2unknownSequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

Colon Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06368141NeoCHICP2recruitingNeoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer

Metastatic Colon Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06335147N/AunknownPD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon Cancer

Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06364046N/AunknownEfficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

Advanced Solid Tumors With Neuroendocrine Differentiation (1)

NCTAcronymPhaseStatusTitle
NCT06156332N/Anot yet recruitingA Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard Therapy

Adenocarcinoma of the Stomach (1)

NCTAcronymPhaseStatusTitle
NCT05872685FOCUS-05P2recruitingPerioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)

Esophageal Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06354218P2recruitingSerplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

Locally Advanced Pancreatic Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05988372SAGEP2not yet recruitingSurufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)

NSCLC Stage IV (1)

NCTAcronymPhaseStatusTitle
NCT05787613P2active not recruitingA Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients

Advanced Solid Tumor (1)

NCTAcronymPhaseStatusTitle
NCT06302062TAL-TP1recruitingPhase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05873790N/AunknownMinimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study

Gastric Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06496789P2recruitingNeoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer

NSCLC (1)

NCTAcronymPhaseStatusTitle
NCT05882513P2active not recruitingSerplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer

Non-small Cell Lung Cancer Stage II (1)

NCTAcronymPhaseStatusTitle
NCT05807893SUPER BRAINP2/P3completedStudy to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain Metastases

Non-Squamous Non-Small Cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT06334757P2unknownSerplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure

Non-clear Renal Cell Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05831891P2active not recruitingFruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell Carcinoma

Advanced Hepatocellular Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT06370065HCCP2unknownSerplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients

Unresectable Colon Cancer Peritoneal Metastases (1)

NCTAcronymPhaseStatusTitle
NCT05742425P2recruitingSerplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal Metastases

Locally Advanced (1)

NCTAcronymPhaseStatusTitle
NCT05766800P2recruitingInduction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

Extensive-stage Small-cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05765825P2active not recruitingStudy of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC

Locally Advanced Colon Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05732493TORCH-CP2unknownShort-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05585580P2active not recruitingSecond-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy

Serplulimab,Gastric Cancer, Adjuvant Therapy (1)

NCTAcronymPhaseStatusTitle
NCT05769725P2unknownA Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer

Neuroendocrine Carcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05747729P1/P2unknownA Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.

pMMR (1)

NCTAcronymPhaseStatusTitle
NCT05731726P2recruitingSerplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

Gastroesophageal Junction Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05918419SNACRTP2unknownEfficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal Junction

Lung Adenocarcinoma (1)

NCTAcronymPhaseStatusTitle
NCT05675033P2unknownSerplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ) (1)

NCTAcronymPhaseStatusTitle
NCT05942573P2unknownContinuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

Extensive Stage Small Cell Lung Cancer (1)

NCTAcronymPhaseStatusTitle
NCT05468489P3active not recruitingTo Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Serplulimab pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
SMARTi-RC01NCT07134101P2not yet recruitingColorectal Cancer (Diagnosis)138
ECTOP-1036NCT07398937P2recruitingResectable Stage II-IIIa Squamous NSCLC116
SPRINGNCT06692491P2not yet recruitingRare Tumour200
SHIELDNCT07506057P2recruitingUrothelial Carcinoma20
FOCUS-05NCT05872685P2recruitingAdenocarcinoma of the Stomach314
SERRACNCT07150949P2recruitingLocally Advanced Rectal Cancer138
ESCCNCT06601309P2recruitingEsophageal Squamous Cell Carcinoma90
SAGENCT05988372P2not yet recruitingLocally Advanced Pancreatic Cancer50
LS-SCLCNCT06911606P2recruitingSCLC, Limited Stage45
StarsNCT06422858P2unknownLocally Advanced Inoperable Esophageal Squamous Cell Carcinoma37
NeoCHICNCT06368141P2recruitingColon Cancer56
ECTOP-1013NCT05775796P2completedNon-small Cell Lung Cancer30PMID 42114951
NSCLCNCT06195683P2unknownNon-small Cell Lung Cancer23
HCCNCT06370065P2unknownAdvanced Hepatocellular Carcinoma35
TORCH-CNCT05732493P2unknownLocally Advanced Colon Cancer120PMID 38309748
SNACRTNCT05918419P2unknownGastroesophageal Junction Adenocarcinoma35

All Serplulimab trials (106)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT06850103SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With OligometastasesP2recruiting51First Affiliated Hospital of Zhejiang UniversityApr 2025
NCT07381400Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)P2not yet recruiting128Xinhua Hospital, Shanghai Jiao Tong University School of MedicineFeb 2026
NCT07177443Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal CarcinomaP3not yet recruiting456Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologySep 2025
NCT07283692Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)P2recruiting46RenJi HospitalMar 2026
NCT07527520Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II TrialP2not yet recruiting165Fudan UniversityJun 2026
NCT07257575A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric AdenocarcinomaP2active not recruiting138Guangdong Provincial People's HospitalJan 2025
NCT07466303Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast CancerP2not yet recruiting84Xijing HospitalMar 2026
NCT07318883A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung CancerP2/P3not yet recruiting720Shanghai Henlius BiotechMar 2026
NCT07141771An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular TypingP1/P2not yet recruiting100Cancer Institute and Hospital, Chinese Academy of Medical SciencesDec 2025
NCT05882513Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung CancerP2active not recruiting36Second Affiliated Hospital, School of Medicine, Zhejiang UniversityMay 2023
NCT07347951A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal CancerP2recruiting30First Affiliated Hospital of Wenzhou Medical UniversityDec 2025
NCT06781281NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.recruiting709Henan Cancer HospitalDec 2024
NCT07155122Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the EsophagealP2not yet recruiting15Fujian Cancer HospitalSep 2025
NCT07134101SMARTi-RC01Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)P2not yet recruiting138The First Affiliated Hospital with Nanjing Medical UniversitySep 2025
NCT06580665Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung CancerN/Anot yet recruiting134Shanghai Chest HospitalSep 2024
NCT07403435Short-course Radiotherapy Combined With Serplulimab and Chemotherapy as Neoadjuvant Treatment for Resectable ESCCP2not yet recruiting22Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyFeb 2026
NCT06860529Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast CancerP2recruiting357Henan Cancer HospitalApr 2025
NCT07398937ECTOP-1036Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLCP2recruiting116Fudan UniversityFeb 2026
NCT06692491SPRINGStudy of Precision Treatment for Rare Tumours in China Guided by PDO and NGSP2not yet recruiting200Peking University Shenzhen HospitalJan 2025
NCT06280495Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC PatientsP2/P3recruiting156Sun Yat-sen UniversityFeb 2024
NCT05659251Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell CarcinomaP2active not recruiting48Second Affiliated Hospital, School of Medicine, Zhejiang UniversityDec 2022
NCT07604909A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant ChemotherapyP2recruiting40Fudan UniversityMay 2026
NCT07506057SHIELDTrastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard TherapyP2recruiting20Xiujuan QuJul 2025
NCT07235930Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic CancerP3recruiting292Zhejiang Cancer HospitalNov 2025
NCT05872685FOCUS-05Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)P2recruiting314Yu jirenDec 2023
NCT05975749Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric CancerP2recruiting114Fudan UniversityJan 2023
NCT07543848A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal CancerP2not yet recruiting20Chongqing University Cancer HospitalMay 2026
NCT07231445Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung CancerP1recruiting100Suzhou Zelgen Biopharmaceuticals Co.,LtdApr 2026
NCT07418866FANLUNG-2:The Value of High-Low Mixed-Dose Radiotherapy Combined With Chemo-Immunotherapy Induction in Locally Advanced Non-Small Cell Lung CancerP2not yet recruiting70Fudan UniversityFeb 2026
NCT07172412Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung CancerP2not yet recruiting165Tianjin Medical University Cancer Institute and HospitalNov 2025
NCT07488533Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell CarcinomaP2active not recruiting40Sun Yat-sen UniversityAug 2025
NCT06394661Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast CancerP2active not recruiting109Henan Cancer HospitalApr 2024
NCT07277842PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal CancerP3not yet recruiting382Sun Yat-sen UniversityDec 2025
NCT07150949SERRACLong-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC)P2recruiting138Fudan UniversityAug 2025
NCT07358585A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal CancerP1/P2not yet recruiting126Shanghai Henlius BiotechJan 2026
NCT07336953A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)P3not yet recruiting198West China HospitalFeb 2026
NCT06419673Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical CancerP2active not recruiting240Cancer Institute and Hospital, Chinese Academy of Medical SciencesMay 2024
NCT05742425Serplulimab Combined With FOLFIRI and Bevacizumab in the Treatment of Colon Cancer Peritoneal MetastasesP2recruiting30Second Affiliated Hospital, School of Medicine, Zhejiang UniversityMar 2023
NCT07020247Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE StudyP3recruiting184West China HospitalNov 2024
NCT07391826Megestrol Acetate Oral Suspension for Cachexia in Patients With cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Receiving Neoadjuvant Therapy With Serplulimab Combined With SOXP2not yet recruiting48The First Affiliated Hospital with Nanjing Medical UniversityFeb 2026
NCT06461910Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction AdenocarcinomaP2recruiting30Zekuan XuJun 2024
NCT06295926Serplulimab Combined With CCRT for LS-SCLC.P2recruiting96Peking Union Medical College HospitalApr 2024
NCT05468489To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLCP3active not recruiting200Shanghai Henlius BiotechNov 2022
NCT06716619A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid TumorsP1recruiting32Guangzhou FineImmune Biotechnology Co., LTD.Feb 2025
NCT07583511Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled StudyP2recruiting90Sun Yat-sen UniversityFeb 2024
NCT06354218Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old AgeP2recruiting50The First Affiliated Hospital with Nanjing Medical UniversityDec 2023
NCT07340489Serplulimab for Locally Advanced Cervical CancerP2recruiting216Tianjin Medical University Cancer Institute and HospitalDec 2025
NCT07134218Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal CancerP2/P3not yet recruiting180Changhai HospitalOct 2025
NCT07175389JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment FailureP1/P2not yet recruiting10West China HospitalOct 2025
NCT06848699A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid TumorsP1/P2recruiting105Shanghai Henlius BiotechFeb 2025
NCT06554535Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung CancerP2not yet recruiting43Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOct 2024
NCT07064876Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung CancerP2not yet recruiting25Xi JunjieOct 2025
NCT06099951Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation TherapyP2not yet recruiting53Sun Yat-sen UniversityNov 2023
NCT05954429A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 StudyP2recruiting50Fudan UniversityJul 2023
NCT06531291Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine DifferentiationP2not yet recruiting80RenJi HospitalAug 2024
NCT06521866Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal CancerP2recruiting208Fudan UniversityMar 2025
NCT05787613A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC PatientsP2active not recruiting132Shanghai Henlius BiotechJul 2023
NCT06128252Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric CancerN/Arecruiting96Tang-Du HospitalSep 2024
NCT06462105Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung CancerN/Anot yet recruiting60Zhou ChengzhiJul 2024
NCT07596121Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%P2recruiting60Tang-Du HospitalMay 2026
NCT06388135Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell CarcinomaP4not yet recruiting80Yang Jianjun, PhDMay 2024
NCT05766800Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung CancerP2recruiting100Shanghai Pulmonary Hospital, Shanghai, ChinaMar 2023
NCT07446465FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal CancerP4not yet recruiting42Ye XuMar 2026
NCT06156332A Study of Surufatinib Combined With Serplulimab in the Treatment of Advanced Solid Tumors With Neuroendocrine Differentiation That Failed Standard TherapyN/Anot yet recruiting39Shanghai Changzheng HospitalJan 2024
NCT06727617Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk FactorsP2recruiting134Tianjin Medical University Cancer Institute and HospitalNov 2024
NCT06497530Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLCP2recruiting30Guangzhou Institute of Respiratory DiseaseDec 2024
NCT06542588Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARCP2recruiting29Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyJul 2024
NCT06439550Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJCP2not yet recruiting42The First Affiliated Hospital of Zhengzhou UniversityJul 2024
NCT06433869The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant AscitesP2recruiting60Sun Yat-sen UniversityDec 2023
NCT05957510Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After TreatmentP2recruiting66Guangdong Association of Clinical TrialsJul 2023
NCT05831891Fruquintinib Plus Serplulimab as First-Line Therapy for Metastatic Non-Clear Cell Renal Cell CarcinomaP2active not recruiting39RenJi HospitalMay 2023
NCT05765825Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLCP2active not recruiting61Sichuan UniversityMar 2023
NCT05731726Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal CancerP2recruiting50Zhejiang UniversityFeb 2023
NCT06601309ESCCBiomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCCP2recruiting90Fujian Medical University Union HospitalJul 2024
NCT07269782A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCP2recruiting60Shanghai Henlius BiotechJan 2026
NCT05585580Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior ImmunotherapyP2active not recruiting59Qilu Hospital of Shandong UniversityMar 2023
NCT05988372SAGESurufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)P2not yet recruiting50Sun Yat-sen UniversityOct 2023
NCT06576921Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric JunctionP2recruiting116Xijing HospitalNov 2024
NCT06491355First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal CancerP2not yet recruiting72Sir Run Run Shaw HospitalJul 2024
NCT06911606LS-SCLCStudy of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)P2recruiting45Guangdong Provincial People's HospitalMay 2024
NCT06302062TAL-TPhase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid TumorsP1recruiting23Guangzhou FineImmune Biotechnology Co., LTD.Jun 2023
NCT05882630Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung CancerP1/P2unknown39Fujian Cancer HospitalJun 2023
NCT06422858StarsSequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell CarcinomaP2unknown37Zhejiang Cancer HospitalMay 2024
NCT06368141NeoCHICNeoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon CancerP2recruiting56Ruijin HospitalMay 2024
NCT05769725A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric CancerP2unknown70RenJi HospitalMar 2023
NCT05747729A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma.P1/P2unknown60Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyFeb 2023
NCT06335147PD1 Antibody Combined With mFOLFOX6 Neoadjuvant Therapy for Advanced Resectable Metastatic Colon CancerN/Aunknown23Henan Cancer HospitalApr 2024
NCT06364046Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLCN/Aunknown56The Central Hospital of Lishui CityApr 2024
NCT06350162Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLCP2unknown100Zhejiang Cancer HospitalOct 2023
NCT06393166Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic CancerP2unknown37Zhejiang Cancer HospitalMay 2023
NCT05883670Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancerunknown118Shandong UniversityMar 2023
NCT05444374A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical CancerP2unknown48Sichuan Cancer Hospital and Research InstituteOct 2022
NCT05775796ECTOP-1013Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)P2completed30Fudan UniversityMar 2023
NCT06334757Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment FailureP2unknown46Henan Cancer HospitalMay 2023
NCT06195683NSCLCSerplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.P2unknown23Zhejiang Cancer HospitalDec 2023
NCT05894837Serplulimab+Regorafenib +Hepatic Artery Bicarbonate Infusion in Patients With Colorectal Cancer and Liver MetastasesP2unknown30Second Affiliated Hospital, School of Medicine, Zhejiang UniversityJun 2023
NCT06455072Nituzumab Plus Serplulimab Combined With SBRT in Cervical CancerP2recruiting37Fujian Cancer HospitalFeb 2023
NCT05873790Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Studyunknown30The First Hospital of Jilin UniversityJun 2023
NCT06496789Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction CancerP2recruiting35Tianjin Medical University Cancer Institute and HospitalMay 2023
NCT06370065HCCSerplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) PatientsP2unknown35Tianjin Medical University Cancer Institute and HospitalApr 2023
NCT05732493TORCH-CShort-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)P2unknown120Fudan UniversityMar 2023
NCT05942573Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II TrialP2unknown107Tianjin Medical University Cancer Institute and HospitalDec 2022
NCT05918419SNACRTEfficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab in Patients With Locally Advanced Adenocarcinoma of Gastroesophageal JunctionP2unknown35Peking Union Medical College HospitalFeb 2023
NCT05501340PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant AscitesP1/P2unknown40Second Affiliated Hospital of Soochow UniversitySep 2022
NCT05807893SUPER BRAINStudy to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain MetastasesP2/P3completed40Sun Yat-sen UniversityMay 2023
NCT05675033Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung AdenocarcinomaP2unknown50Fujian Cancer HospitalJan 2023

Serplulimab clinical trials: frequently asked questions

How many Serplulimab clinical trials are there?
106 Serplulimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 42 are actively recruiting participants. 2 are marked completed.
Are Serplulimab clinical trials recruiting in 2026?
Yes — 42 Serplulimab trials are actively recruiting in 2026. See the recruiting trials and the per-state site list further down this page.
What conditions is Serplulimab being studied for?
Serplulimab is being studied for Immunotherapy, Cervical Cancer, Small Cell Lung Cancer, Colorectal Cancer, Neoadjuvant Therapy and 115 more. The trials are grouped by indication on this page.
What phase is Serplulimab in?
Serplulimab clinical trials span 2 Phase 4, 6 Phase 3, 75 Phase 2, 3 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Serplulimab clinical trials?
The lead sponsor across the most Serplulimab trials is Fudan University, with 49 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Serplulimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed .

Related pages on Hipa.ai: