ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.
Disqualifiers
Any contraindication to cetuximab and/or envafolimab. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
Trial design
Treatments tested in this trial
- irinotecan, cetuximab, envafolimab
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Hospital
Lead sponsor
Bethune Charitable Foundation
Collaborator
Source ClinicalTrials.gov