RecruitingPhase 2NCT06427005

Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC

Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study


Sponsor

Meng Qiu

Enrollment

66 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — fruquintinib, S-1, and raltitrexed — for people with metastatic colorectal cancer that has stopped responding to standard chemotherapy. All three drugs target cancer cell growth through different pathways. **You may be eligible if...** - You are 18 or older - You have metastatic colorectal cancer confirmed by biopsy - Your cancer has progressed after standard treatments including 5-FU, irinotecan, and oxaliplatin (and targeted drugs if applicable) - You have measurable tumors on scans - You are in good overall health (ECOG 0–2) - You have a life expectancy of at least 12 weeks - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have had a recent chemotherapy session without adequate recovery time - Your blood counts or organ function fall below study thresholds - You are pregnant or breastfeeding - You have an active serious infection 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

Fruquintinib 5 mg daily for 14 days followed by a 7-day break

DRUGS-1

S-1 80-120 mg daily for 14 days, followed by a 7-day break

DRUGraltitrexed

raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg


Locations(2)

Sichuan University West China Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT06427005


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