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

Sponsor
Xijing Hospital
Study ID
NCT06576921
Phase
PHASE2
Status
Recruiting
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Conditions

  • Immune Checkpoint Inhibitors
  • Stomach Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab Combined With Chemotherapy — DRUG
    Serplulimab (Dosage form: Lyophilized powder; Unit dose strength: 4.5 mg; Route of administration: IV infusion; Storage requirements: 2-8℃. Protect from light and freezing.) Nap-paclitaxel (Dosage form: Lyophilized powder; Unit dose strength: 100 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) S-1 (Dosage form: Capsule; Unit dose strength: 20 mg; Route of administration: Oral; Storage requirements: 20-30℃. Protect from light.) Oxaliplatin (Dosage form: Lyophilized powder; Unit dose strength: 50 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) Surgery: All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer.
  • Placebo combined with Chemotherapy — DRUG
    Placebo (Dosage form: Lyophilized powder; Unit dose strength: 4.5 mg; Route of administration: IV infusion; Storage requirements: 2-8℃. Protect from light and freezing.) Nap-paclitaxel (Dosage form: Lyophilized powder; Unit dose strength: 100 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) S-1 (Dosage form: Capsule; Unit dose strength: 20 mg; Route of administration: Oral; Storage requirements: 20-30℃. Protect from light.) Oxaliplatin (Dosage form: Lyophilized powder; Unit dose strength: 50 mg; Route of administration: IV infusion; Storage requirements: \<25℃. Protect from light.) Surgery: All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer.

Study Details

This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are: Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. Participants will: Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.

Key Dates

Start date
Nov 15, 2024
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: S-P-SOX group
    Neoadjuvant treatment phase: 1.Serplulimab, 4.5 mg intravenously on day 1; 2.Nap-paclitaxel, 260 mg/m2 intravenously on days 1; 3.Oxaliplatin (OXA), 130mg/ /m2, intravenously on days 1; 4.Tigio (S-1), 40-60 mg orally twice daily on days 1 to 14. The above treatments will be administered every 3 weeks for three preoperative cycles. Dose adjustment is not allowed and delayed dosing is allowed. Surgery phase: Surgery was scheduled 3 to 4 weeks after completion of the last cycle of neoadjuvant treatment. All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer. Adjuvant treatment phase: Adjuvant treatment started 3 to 8 weeks after surgery. Patients will receive three 3-week cycles of adjuvant treatment with S-P-SOX.
  • Placebo Comparator: P-SOX group
    Neoadjuvant treatment phase: 1.Nap-paclitaxel, 260 mg/m2 intravenously on days 1; 2.Oxaliplatin (OXA), 130mg/ /m2, intravenously on days 1; 3.Tigio (S-1), 40-60 mg orally twice daily on days 1 to 14. The above treatments will be administered every 3 weeks for three preoperative cycles. Dose adjustment is not allowed and delayed dosing is allowed. Surgery phase: Surgery was scheduled 3 to 4 weeks after completion of the last cycle of neoadjuvant treatment. All surgical procedures are performed according to the guidelines of the Japanese Research Society for the Study of Gastric Cancer. Adjuvant treatment phase: Adjuvant treatment started 3 to 8 weeks after surgery. Patients will receive three 3-week cycles of adjuvant treatment with P-SOX.

Primary Outcome Measure

Pathological complete response rate (pCR) [ Time Frame: 3 weeks after completion of the neoadjuvant treatment phase ]

Central Contacts

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