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Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

The Efficacy and Safety of Fruquintinib Plus FOLFIRI as Second-line Treatment in RAS-mutated Metastatic Colorectal Cancer

NCT05842525•Hunan Cancer Hospital

View on ClinicalTrials.gov

Summary

RAS mutations are found in nearly half of colorectal cancer patients. However, except for G12C mutation, no driven gene targeted drug can be used. the commonly first-line used treatment regimen is bevacizumab combined with chemotherapy. Angiogenesis is an important therapeutic target in colorectal carcinoma. Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory colorectal cancer.

Detailed Description

This is a prospective ,single-center, open labeled, single-arm phase II study exploring the efficacy and safety of fruquintinib combined with FOLFIRI as second-line treatment of RAS-mutated metastatic colorectal cancer (mCRC) in patients with disease progression during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological or cytological confirmed colorectal cancer;
•2. RAS mutation;
•3. Expected survival \>12 weeks;
•4. Patients had disease progression during or within 3 months of the last dose of first-line therapy, which must include bevacizumab combined with oxaliplatin, and a fluoropyrimidine;
•5. ECOG PS 0-1;
•6. At least one measurable lesion (according to RECIST1.1);
•7. Adequate hepatic, renal, heart, and hematologic functions;
•8. Negative serum pregnancy test at screening for women of childbearing potential.
•\-

Exclusion Criteria

•1. MSI-H / dMMR;
•2. Received radiation therapy, surgical procedure, immunotherapy or other investigational drugs within 4 weeks prior to treatment ;
•3. Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
•4. Prior treatment with an irinotecan-based chemotherapy regimen;
•5. Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
•6. Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
•7. Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
•8. Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
•9. Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction \< 50%, arrhythmia control is not good;
•10. The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); Allergy to the study drug or any of its excipients;
+2 more criteria

Locations (1)

Hunan Cancer hospital

Changsha, Hunan, China

Key Dates

Start Date

October 1, 2023

Primary Completion Date

May 28, 2024

Completion Date

December 30, 2024

Last Updated

August 1, 2023

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

intensive treatment

DRUG

Maintenance treatment

DRUG

Contacts

zhenyang Liu, MD PhD

CONTACT

0731-89762131 liuzhenyang@hnca.org.cn

xiaolin Yang, MD

CONTACT

0731-89762131'yangxiaolin@hnca.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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