drugset / Trial / NCT06321081

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

NCT06321081

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-03-01
Primary completion
2026-02-14
Completion
2026-08-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2
Subject Envafolimab Monoclonal antibody 200 mg
Subject Irinotecan Small molecule 150 mg/m2