Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

Launched by FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE · Aug 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medicine called fruquintinib works for people with metastatic colorectal cancer, which means the cancer has spread beyond the colon or rectum. The main goal is to find out which factors—like certain biological or clinical features—can help predict how well patients will do when treated with fruquintinib, especially in terms of overall survival.

Patients who are 18 years or older, have a confirmed diagnosis of advanced colorectal cancer that cannot be removed by surgery, and are receiving fruquintinib treatment in France may be eligible to join. Participants will be asked to give their consent to be part of the study and to provide some biological samples, such as blood tests and tumor tissue, to help researchers better understand the treatment’s effects. Women who are pregnant or breastfeeding, people with other active cancers, or those who might have difficulty staying in the study for social or psychological reasons will not be eligible. The study is not yet recruiting, but it aims to help doctors learn more about who benefits most from fruquintinib, potentially improving treatment decisions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).