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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederation Francophone de Cancerologie Digestive

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Fruquintinib

    Drug

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: FruquintinibOther 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

OS is defined as the time interval (months) between the date of initiation of treatment with fruquintinib and the date of death (from any cause).

Time frame
up to 1 year after treatment start

Secondary outcomes

1

progression free survival

Time (months) from initiation of treatment with fruquintinib to radiological and/or clinical tumour progression or death from any cause.

Time frame
up to 1 year after treatment start

Other outcomes

Sponsors and contacts

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