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ClinicalTrials.gov ID

NCT07124858

Lead Sponsor

Federation Francophone de Cancerologie DigestiveOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

May 26, 2026Actual

Start Date

Mar 10, 2026Actual

Primary Completion Date

Mar 1, 2031Estimated

Completion Date

Dec 31, 2031Estimated

Official Title

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

Brief 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.

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.

• Metastatic Colorectal Cancer (CRC)
• Antineoplastic Agents, Immunological
• VEGFR-TKI

• Fruquintinib

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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).

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Federation Francophone de Cancerologie DigestiveOTHER

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