RecruitingPhase 2NCT07136077

A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy


Sponsor

M.D. Anderson Cancer Center

Enrollment

20 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — fruquintinib (a targeted therapy) and tislelizumab (an immunotherapy) — in people with colorectal cancer who have no visible signs of disease on scans but still show traces of cancer DNA in their blood (called ctDNA), suggesting a high risk of the cancer coming back. **You may be eligible if...** - You have confirmed colorectal cancer (microsatellite stable type, MSS) - You have completed curative treatment for stage II, III, or IV colorectal cancer, including at least 3 months of oxaliplatin-based chemotherapy - There is no visible cancer on recent imaging - A blood test (ctDNA assay, such as Signatera) performed at MD Anderson or a certified lab shows cancer DNA in your blood **You may NOT be eligible if...** - Your ctDNA test is negative (no cancer DNA detectable) - You have visible cancer on scans - Your colorectal cancer has a microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) profile (a different category that responds to other treatments) 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

DRUGTislelizumab

Given by IV

DRUGFruquintinib

Give by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT07136077


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