RecruitingPhase 2NCT06010888

Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC

Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC: An Exploratory Clinical Trial


Sponsor

Fudan University

Enrollment

92 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the efficacy and safety of Fruquintinib with mFOLFOX6/FOLFIRI in patients with mCRC. The main question it aims to answer is: The conversion surgery rate of the therapy mentioned above. The ORR, R0 surgery rate, DCR, PFS, OS, and safety will be evaluated.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of fruquintinib (a targeted anti-cancer drug) with standard chemotherapy (mFOLFOX6 or FOLFIRI) as a first-line treatment for people with metastatic colorectal cancer (cancer that has spread). The goal is to shrink the cancer enough so surgery becomes possible. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic colorectal cancer - You have not received prior systemic treatment for metastatic disease (or recurrence occurred more than 6 months after completing earlier chemotherapy) - You are in good health (ECOG 0–1) with a life expectancy of at least 3 months - Your tumor's RAS/BRAF status has been tested - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have received prior systemic anti-cancer treatment for metastatic disease - Your recurrence happened within 6 months of completing prior chemotherapy - Your blood counts or organ function are significantly impaired - You are pregnant, breastfeeding, or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib+mFOLFOX6/FOLFIRI

Fruquintinib: 4mg po qd, d1-d21, q4w with mFOLFOX6/FOLFIRI (standard)


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06010888


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