Phase II Study of Irinotecan, Cetuximab, and Envafolimab Combination as Rechallenge Treatment in Metastatic Colorectal Cancer with RASBRAF Wild Type

What this Trial Is About

Researchers are evaluating the combination of irinotecan, cetuximab, and envafolimab as a rechallenge treatment for patients with metastatic colorectal cancer who have specific genetic profiles RASBRAF wild type confirmed by liquid biopsy. This phase II, non-profit, open-label study targets patients previously treated with irinotecan and cetuximab who showed complete or partial responses, regardless of prior PD-1 inhibitor use. In this study, 30 patients will receive irinotecan 150mgm2 every 2 weeks, cetuximab 500mgm2 every 2 weeks, and envafolimab 200mg every 2 weeks. Before treatment and at disease progression, blood samples will be collected to analyze circulating tumor DNA. Treatment will continue until disease progression, significant clinical decline, or other withdrawal criteria are met. Continued treatment past initial disease progression may be possible if patients maintain stable performance status and show no worsening symptoms. Participants will be monitored regularly throughout treatment. Researchers will assess progression-free survival over up to 36 months from therapy start, along with overall survival. Blood samples and clinical evaluations will occur at baseline and during disease progression. Safety, treatment response, and patient health status will be closely observed until study completion, expected by the end of 2026.

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