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.

Trial Details

NCT ID
NCT06321081
Phase
PHASE2
Sponsor
Beijing Hospital
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • irinotecan, cetuximab, envafolimab
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.
  • Male or female subjects aged ≥ 18 years. Histologically proven diagnosis of colorectal adenocarcinoma. Diagnosis of metastatic disease. RAS (NRAS a…
  • More than 2 months since the last dose of cetuximab administered in first line treatment before randomization.
  • Measurable disease according to RECIST criteria v1.1. ECOG PS of 0 to 1 at trial entry. Estimated life expectancy of more than 12 weeks. Adequate h…

For full eligibility, visit ClinicalTrials.gov.

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