Clinical Trial

5-fluorouracil Plus Panitumumab (Anti-EGFR) and Sotorasib (KRAS G12C Inhibitor) in First-line Treatment of Patients Non-eligible for a Doublet/Triplet Chemotherapy With Advanced Unresectab

Study acronym: COLOSOTO
Not Yet Recruiting Phase 2
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Summary
5-fluorouracil (5-FU) is a standard of care in frail/elderly patients with an unresectable colorectal adenocarcinoma (CRC) in first-line setting. Panitumumab plus Sotorasib are promising in advanced line in KRAS G12C mutated CRC. In this study, We assess the safety and efficacy of 5FU combination with Panitumumab and Sotorasib as first-line treatment in frail/elderly patients with unresectable KRAS G12C mutated CRC
Trial Details
NCT Number NCT07124884
Lead Sponsor Federation Francophone de Cancerologie Digestive
Collaborators: Northwest Oncology Cooperative Group(GONO), Arbeitsgemeinschaft fur Internistische Onkologie, Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Conditions Colorectal Carcinoma, KRAS G12C Mutation, Unresectable Colorectal Cancer
Enrollment 300 participants
Start Date 2025-08-31
Primary Completion 2030-06-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-15