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

PHASE2RecruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

August 1, 2027

Conditions
Advanced Colorectal CarcinomaImmunotherapy
Interventions
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

Trial Locations (10)

200030

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

223001

NOT_YET_RECRUITING

Huai'an Second People's Hospital, Huaian

250000

NOT_YET_RECRUITING

Qianfoshan Hospital of Shandong Province, Jinan

271000

NOT_YET_RECRUITING

Taian City Central Hospital, Taian

350000

NOT_YET_RECRUITING

Fujian Cancer Hospital, Fuzhou

361000

NOT_YET_RECRUITING

The First Affiliated Hospital of Xiamen University, Xiamen

450000

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

455000

NOT_YET_RECRUITING

Anyang Cancer Hospital, Anyang

650000

NOT_YET_RECRUITING

Yunnan Cancer Hospital, Kunming

730000

NOT_YET_RECRUITING

Lanzhou Military Region General Hospital, Lanzhou

All Listed Sponsors
lead

Fudan University

OTHER