Abstract 163TiP
Background
Rechallenge therapy for RAS WT/MSS refractory metastatic colorectal cancer (mCRC) is an emerging therapeutic approach. CAVE and AVETUXIRI showed it could be promising to treat such kind of patiens with CET,CPT-11 and PD-L1. We had explored some cases with ICE regiemn (Irinotecan Plus Cetuximab and Envafolimab, Envafolimab is a new PD-L1 which was used by subcutaneous injection) and found it had good ORR and PFS.
Trial design
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 and MSS 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.Any RAS WT/MSS mCRC patients who had got benefits from cetuximab or irinotecan will be treated with ICE regimen (Irinotecan 150mg/m2,Q2W, cetuximab 500mg/m2, Q2W, envafolimab 200mg, Q2w). The end point is PFS and the second end poing is OS and ORR.
Clinical trial identification
NCT06321081.
Legal entity responsible for the study
The authors.
Funding
Bethune Charitable Foundation.
Disclosure
All authors have declared no conflicts of interest.