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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
irinotecan, cetuximab, envafolimab
Drugrechallenge treatment
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ICE treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
progression free survival
the interval from enrollment to disease progression
Time frame
from screening up to 36 months (from the start of therapy until disease progression or death due to any causeSecondary outcomes
1
Overal survival
the interval from enrollment to death for every cause.
Time frame
from screening up to 36 months (from the start of therapy until death due to any causeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Hospital
Lead sponsor
Bethune Charitable Foundation
Collaborator
Source ClinicalTrials.gov