Prognostic Factors for Fruquintinib in Metastatic Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective national cohort will collect clinical and biomarker data from adults with metastatic colorectal cancer treated with fruquintinib in France. It aims to validate survival and safety outcomes seen in prior trials and to identify prognostic and predictive factors of response, including data from older patients and geriatric assessments. Biological samples such as ctDNA and tumor blocks may be collected to support pharmacokinetic analyses. The study builds on existing approvals and compassionate use of fruquintinib and seeks to optimize patient selection for maximal benefit. Participation is observational and all care decisions remain at the treating clinicians’ discretion.

Why it matters

Who can join: the full rules

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).

Where it's running

• Poitiers CHU
  Poitiers, France, France Recruiting
• Centre Hospitalier
  Albi, France Recruiting
• Chu
  Amiens, France Recruiting
• Clinique de L Europe
  Amiens, France Recruiting
• Centre Hospitalier
  Annecy, France Recruiting
• Centre Hospitalier
  Aurillac, France Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.