A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

590

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

June 30, 2030

Conditions
Metastatic Colorectal Cancer (CRC)
Interventions
DRUG

Cetuxima-β

500 mg/m², initial intravenous infusion (IV)\>120 min, subsequent IV \>60 min , D1,every 2 weeks

DRUG

Envafolimab

a single fixed dose of 200 mg, subcutaneous injection(SC), every 2 weeks (Day 1 of each cycle \[D1\])

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m² , IV, over 120 min, Day 1; Leucovorin 400 mg/m² (or Calcium Folinate 200 mg/m²), IV, over 120 min, D1; 5-FU 400 mg/m² , bolus injection, followed by 1200 mg/(m²·d) continuous IV for 2 days (total dose 2400 mg/m² over 46 - 48 hours)

Trial Locations (1)

510075

Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER