Actively Recruiting
Study of Cadonilimab With Bevacizumab and FOLFOX as First Treatment for Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer A Single-Arm Phase II Multicenter Trial
Led by Fudan University · Updated on 2024-01-23
53
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying a combination treatment of Cadonilimab, bevacizumab, and FOLFOX chemotherapy for adults with advanced, unresectable metastatic colorectal cancer that is microsatellite stable MSS and has a RAS mutation. This Phase II, single-arm, open-label, multicenter trial aims to observe the one-year progression-free survival rate and other outcomes like overall response rate, perioperative safety, and long-term survival in this patient population. Participants will receive the combination of Cadonilimab, bevacizumab, and the FOLFOX chemotherapy regimen as their first-line treatment. This study includes only one experimental treatment group and focuses on evaluating the effects and safety of this combined therapy over time. During the trial, participants will be closely monitored with regular assessments to track their disease progression, treatment response, and any side effects. Researchers will measure outcomes such as the one-year progression-free survival rate, overall response rate, adverse event rates, progression-free survival, and overall survival over 24 months. The study will last up to two years, including safety follow-up and long-term observation.
CONDITIONS
Brief Title
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer
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