drugset / Trial / NCT06321081
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | — |
| Subject | Envafolimab | Monoclonal antibody | 200 mg | — |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |