NCT06321081

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-profit phase II, open-label, clinical study of the combination 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. 30 patients will be treated with irinotecan plus cetuximab and envafolimab. For each patient, before treatment, a blood sample will be obtained and analyzed for circulating free tumorDNA, to identify RAS/BRAF wild type patient to be enrolled. The same procedure will be performed at progression of the disease. Treatment will continue until: disease progression. significant clinical deterioration any criterion for withdrawal from the trial or trial drug is fulfilled treatment may continue past the initial determination of disease progression according to RECIST 1.1. if the subject's performance status has remained stable, and if in the opinion of the Investigator, the subject will benefit from continued treatment and if other criteria are fulfilled as outlined in the protocol, that is, no new symptoms or worsening of existing symptoms and no decrease in performance score.

Conditions

• RAS Mutation
• Metastatic Colorectal Cancer
• MSS

Interventions

Type	Name	Description
DRUG	irinotecan, cetuximab, envafolimab	rechallenge treatment

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-02-14
• Completion: 2026-08-14
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: China