RecruitingPhase 2Phase 3NCT06441565

Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer

Fruquintinib Plus Arterial Infusion Therapy With Hepatic FOLFOX for Refractory Colorectal Cancer: The FAITH Randomized Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

84 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this clinical trial is to evaluate the efficacy and safety of combining fruquintinib with hepatic artery infusion (HAI)-FOLFOX in the treatment of refractory colorectal cancer with liver metastasis.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a liver-directed chemotherapy technique called hepatic arterial infusion (HAI-FOLFOX) — delivering chemo directly into the liver's blood supply — to a drug called fruquintinib improves outcomes for people with colorectal cancer that has spread to the liver and stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer (bowel cancer) confirmed to have spread to the liver - Your cancer has stopped responding to standard chemotherapy regimens - Your liver tumors are the main site of disease (with no or very minimal spread elsewhere) **You may NOT be eligible if...** - Your cancer has spread significantly beyond the liver - You have serious liver, heart, or kidney problems - You have already received fruquintinib or regorafenib - You are pregnant or breastfeeding 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

A treatment cycle of 4 weeks, with 5 mg orally once daily for 3 weeks, followed by a 1-week break

DRUGFluorouracil

2.8 g/m² (400mg bolus + 2.4g/m² continuous infusion) given every 2 weeks through hepatic arterial infusion

DRUGOxaliplatin

85 mg/m² given every 2 weeks through hepatic arterial infusion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06441565


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