Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer
Summary
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.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2026-08-01
- Completion
- 2027-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Serplulimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |