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

May 22, 2026 updated by: Federation Francophone de Cancerologie Digestive

PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically.

Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters.

The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib.

As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Amiens, France
      • Amiens, France
      • Annecy, France
      • Aurillac, France
      • Bayeux, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Bayonne, France
      • Beauvais, France
      • Besançon, France
      • Beuvry, France
        • Recruiting
        • Centre Pierre Curie
        • Contact:
      • Beuvry, France
      • Bordeaux, France
      • Bordeaux, France
        • Recruiting
        • Polynclinique Bordeaux Nord Aquitaine
        • Contact:
      • Brest, France
      • Caen, France
      • Calais, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Caluire-et-Cuire, France
      • Chalon-sur-Saône, France
        • Recruiting
        • Clinique Sainte Marie
        • Contact:
      • Chambray-lès-Tours, France
        • Recruiting
        • ROC37
        • Contact:
      • Chartres, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Cholet, France
      • Compiègne, France
      • Corbeil-Essonnes, France
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
      • Coudekerque-Branche, France
        • Recruiting
        • Clinique Branche - Clinique Flandres
        • Contact:
      • Créteil, France
        • Recruiting
        • Centre Hospitalier Henri Mondor
        • Contact:
      • Dechy, France
        • Recruiting
        • Centre Leonard de Vinci
        • Contact:
      • Dijon, France
      • Dijon, France
        • Recruiting
        • Institut de Cancérologie de Bourgogne
        • Contact:
      • Flers, France
      • Fréjus, France
      • Férolles-Attilly, France
        • Recruiting
        • Hopital Prive Forcilles
        • Contact:
      • Grenoble, France
        • Recruiting
        • Groupe Hospitalier Mutualiste
        • Contact:
      • La Chaussée-Saint-Victor, France
        • Recruiting
        • Polyclinique de Blois
        • Contact:
      • La Roche-sur-Yon, France
        • Recruiting
        • Centre Hospitalier de Vendee
        • Contact:
      • La Réunion, France
      • Le Havre, France
        • Recruiting
        • Hopital Prive de L Estuaire
        • Contact:
      • Le Puy-en-Velay, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Lens, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Lille, France
      • Limoges, France
      • Lorient, France
        • Recruiting
        • Groupement Hospitalier Bretagne Sud
        • Contact:
      • Lyon, France
        • Recruiting
        • Clinique Jean Mermoz
        • Contact:
      • Marseille, France
      • Marseille, France
      • Marseille, France
      • Maubeuge, France
      • Montbéliard, France
        • Recruiting
        • Ch Du Mittan
        • Contact:
      • Nancy, France
        • Recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
      • Nantes, France
      • Neuilly, France
        • Recruiting
        • Clinique Ambroise Pare Hartmann
        • Contact:
      • Neuilly-sur-Seine, France
      • Niort, France
      • Orléans, France
      • Paris, France
        • Recruiting
        • Hôpital Saint Louis
        • Contact:
      • Paris, France
        • Recruiting
        • Saint Antoine
        • Contact:
      • Paris, France
        • Recruiting
        • Hôpital Avicenne
        • Contact:
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon
        • Contact:
      • Paris, France
      • Paris, France
        • Recruiting
        • BICHAT
        • Contact:
      • Paris, France
      • Pau, France
      • Percy, France
      • Perpignan, France
      • Pessac, France
      • Pierre-Bénite, France
      • Plérin, France
      • Poitiers, France
      • Reims, France
      • Rennes, France
      • Rouen, France
      • Saint-Denis, France
      • Soissons, France
      • St-Malo, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Strasbourg, France
        • Recruiting
        • Clinique Sainte Anne
        • Contact:
      • Thonon-les-Bains, France
      • Toulouse, France
      • Tours, France
      • Valence, France
        • Recruiting
        • Hôpital Privé Drôme Ardèche
        • Contact:
      • Vandœuvre-lès-Nancy, France
      • Versailles, France
        • Recruiting
        • Centre hospitalier
        • Contact:
      • Villefranche-sur-Saône, France
        • Recruiting
        • Hopital Nord Ouest
        • Contact:
      • Villeurbanne, France
        • Recruiting
        • Medipole Hopital Mutualiste
        • Contact:
    • France
      • Poitiers, France, France, 86021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fruquintinib
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.
Drug: Fruquintinib
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to 1 year after treatment start
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).
up to 1 year after treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: up to 1 year after treatment start
Time (months) from initiation of treatment with fruquintinib to radiological and/or clinical tumour progression or death from any cause.
up to 1 year after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

August 8, 2025

First Submitted That Met QC Criteria

August 14, 2025

First Posted (Actual)

August 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COFRUQ COHORT
  • 2024-A00994-43 (Registry Identifier: ID RCB ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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