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

Sponsor
Fudan University
Study ID
NCT06521866
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Colorectal Carcinoma
  • Immunotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    IV 3 mg/kg on Day 1, q2w
  • Chemotherapy — DRUG
    Induction therapy：Oxaliplatin: 85 mg/m² IV on Day 1 Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours Maintenance therapy: Leucovorin (LV): 400 mg/m² IV on Day 1 5-FU: 400 mg/m² IV bolus on Day 1, then 2400 mg/m² continuous IV infusion over 46-48 hours
  • SABR — RADIATION
    SABR: 25-60 Gy/5 Fx
  • Targeted therapy — DRUG
    Cetuximab: 400 mg/m² IV on Day 1, then 250 mg/m² IV weekly ; Bevacizumab: 5 mg/kg IV on Day 1

Study Details

Study Title: A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with Targeted Therapy, Chemotherapy, and Optional Radiotherapy in Advanced Colorectal Cancer Study Objective: To explore the efficacy and safety of immune checkpoint inhibitor combined with targeted therapy and chemoradiotherapy in locally advanced unresectable or metastatic colorectal cancer. Study Population: Patients with left-sided wild-type, right-sided, or RAS-mutant advanced colorectal cancer who have not received systemic treatment. Study Endpoints: Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), safety, and R0 resection rate. Study Design: Prospective, randomized Phase II clinical study.

Key Dates

Start date
Mar 1, 2025
Status verified
Mar 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

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

Arms

  • Experimental: Group A
    Group A (Left-sided wild-type): Induction Treatment (12 cycles): Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion \>2 hours, then 250 mg/m² IV infusion ≥60 min), weekly mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Maintenance therapy: Serplulimab: IV 3 mg/kg on Day 1, q2w Cetuximab: 400 mg/m² IV infusion (1st infusion \>2 hours, then 250 mg/m² IV infusion ≥60 min), weekly 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w
  • Experimental: Group B
    Group B (Left-sided wild-type): One cycle of Serplulimab combined with Cetuximab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Cetuximab and chemotherapy.
  • Experimental: Group C
    Group C (Right-sided or RAS-mutant): Induction Treatment (12 cycles): Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w mFOLFOX6: Oxaliplatin: 85 mg/m² IV over 2 hrs, Day 1 LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w Maintenance Treatment: Serplulimab: IV 3 mg/kg on Day 1, q2w Bevacizumab: 5 mg/kg IV on Day 1, q2w 5-FU/LV: LV: 400 mg/m² IV over 2 hrs, Day 1 5-FU: 400 mg/m² IV push, Day 1; 2400 mg/m² IV over 46-48 hrs q2w
  • Experimental: Group D
    Group D (Right-sided or RAS-mutant): One cycle of Serplulimab combined with Bevacizumab and chemotherapy, followed by Stereotactic ablative radiotherapy（SABR: 25-60 Gy/5 Fx）, then continued Serplulimab combined with Bevacizumab and chemotherapy.

Primary Outcome Measure

PFS [ Time Frame: 2 year ]

Central Contacts

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