Phase 3 Study of Continuing Cetuximab With Chemotherapy Compared to Bevacizumab in Adults with RASBRAF Wild-Type Metastatic Colorectal Cancer After First-Line Progression

What this Trial Is About

Researchers are evaluating whether continuing cetuximab treatment beyond first-line progression can improve outcomes in adults with metastatic colorectal cancer who have tumors that are RAS and BRAF wild-type. This Phase 3 clinical trial aims to compare chemotherapy combined with cetuximab versus chemotherapy combined with bevacizumab, focusing on tumor response, progression-free survival, overall survival, and safety. The study builds on prior trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will be randomly assigned to receive either FOLFOX or FOLFIRI chemotherapy combined with cetuximab experimental group or bevacizumab control group. Treatments are given every two weeks, with cetuximab administered as a 120-minute intravenous infusion at 500 mgm and bevacizumab at 5 mgkg. Therapy continues until disease progression, unacceptable side effects, or patient withdrawal. Tumor response will be assessed by independent review using RECIST criteria. During the study, patients undergo regular CT or MRI scans, laboratory tests, and clinical evaluations. Biological samples such as tumor tissue, blood, and stool are collected for research on resistance mechanisms and the gut microbiome. The primary measure is the overall response rate assessed up to 48 months, with secondary outcomes including overall survival, progression-free survival, and safety monitored throughout treatment and up to 30 days after the last dose. Participation lasts through treatment and follow-up periods up to several years.

Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer