Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

November 9, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

December 31, 2027

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Cetuximab + Envafolimab + mFOLFOXIRI

Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + envafolimab 200mg + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.

DRUG

Cetuximab + mFOLFOX6/FOLFIRI

Cetuximab 500mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h or cetuximab 500mg/m² + irinotecan 180 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to max 8 cycles, followed by maintenance with cetuximab 500mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle until PD, unacceptable toxicity or patient's refusal.

Trial Locations (3)

510655

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

528000

RECRUITING

The First People's Hospital of Foshan, Foshan

550000

RECRUITING

Affiliated Cancer Hospital of Guizhou Medical University, Guiyang

All Listed Sponsors
lead

Sun Yat-sen University

OTHER