Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
Federation Francophone de Cancerologie Digestive
300 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
Summary
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Eligibility
Inclusion Criteria4
- Patients aged 18 and over.
- Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
- Obtain informed consent from the patient for the clinical-biological cohort.
- Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
Exclusion Criteria4
- Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
- Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
- Pregnant or breast-feeding women.
- Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
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Interventions
Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
Locations(83)
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NCT07124858