RecruitingPhase 2NCT06992258

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer


Sponsor

Criterium, Inc.

Enrollment

120 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy combinations — fruquintinib with TAS-102 versus fruquintinib with bevacizumab — in patients with advanced colorectal cancer that has already been treated with standard therapies. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic colorectal cancer - You have already received standard chemotherapy regimens (fluoropyrimidine, oxaliplatin, irinotecan) plus targeted antibody therapies appropriate for your cancer type - Your cancer has a functioning DNA repair system (called mismatch repair proficient or MMRp) - You have at least one measurable tumor - You are in good enough health to participate (ECOG 0–1) **You may NOT be eligible if...** - You have not yet received the standard first- and second-line chemotherapy regimens - You have poor organ function (kidney, liver, blood counts below acceptable levels) - You cannot swallow oral medications 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+ Lonsurf (trifluridine and tipiracil)

Experimental arm

DRUGFruquintinib

Standard Of Care Arm


Locations(9)

Yale University

New Haven, Connecticut, United States

Mount Sinai Cancer Research Program

Miami Beach, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

NYU Langone Health

New York, New York, United States

UPenn Lancaster-Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Mays Cancer Center at University of Texas Health at San Antonio

San Antonio, Texas, United States

Inova Schar Cancer

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06992258


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