drugset
drugset / Trial / NCT06959693

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)

NCT06959693 ↗

Phase 2/3 Not yet recruiting 590 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Timeline

Start
2025-06-01
Primary completion
2028-09-30
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuxima-β Unknown 500 mg/m2 Intravenous
Subject Envafolimab Monoclonal antibody 200 mg Subcutaneous
Background Leucovorin Small molecule 200 mg/m2 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 1200 mg/m2 Intravenous

Indications

colorectal cancer