NCT06521866

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

A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Colorectal Carcinoma
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Serplulimab	IV 3 mg/kg on Day 1, q2w
DRUG	Chemotherapy	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
RADIATION	SABR	SABR: 25-60 Gy/5 Fx
DRUG	Targeted therapy	Cetuximab: 400 mg/m² IV on Day 1, then 250 mg/m² IV weekly ; Bevacizumab: 5 mg/kg IV on Day 1

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-07-26
• Last updated: 2025-03-14

Locations

10 sites across 1 country: China