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
Age ≥ 18 years.
Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma.
Proven KRAS G12C mutation as locally assessed by means of an IVDR-compliant test
Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency.
Patients with high microsatellite instability (MSI-H) or a tumour with mismatched repair (dMMR).
Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments).
Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL).
Federation Francophone de Cancerologie Digestive
Lead sponsor
Northwest Oncology Cooperative Group(GONO)
Collaborator
Arbeitsgemeinschaft fur Internistische Onkologie
Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborator