ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC

This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.

NCT Number	NCT06321081
Lead Sponsor	Beijing Hospital Collaborators: Bethune Charitable Foundation
Conditions	RAS Mutation, Metastatic Colorectal Cancer, MSS
Enrollment	60 participants
Start Date	2024-03-01
Primary Completion	2026-12-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-28