Active — Not RecruitingPhase 2

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

United States15 participantsStarted 2025-09-18

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligibility Criteria * Participants must have histologically or cytologically confirmed microsatellite stable (MSS) colorectal adenocarcinoma. * Participants must have completed curative intent treatments of stages II, III, or IV colorectal cancer that must include ≥ 3 months of oxaliplatin containing chemotherapy. * No evidence of radiographic disease within 28 days (before or after) a positive ctDNA assay. * Participants must have minimal residual disease as defined by positive ctDNA assay by Signatera MRD assay. * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count of ≥1.0×109/L * Platelet count of ≥100×109/L * Hemoglobin ≥9 g/dL * Serum total bilirubin ≤1.5× upper limit of normal (ULN) (total bilirubin must be \<3× ULN for participants with documented Gilbert's syndrome). * Participants must have ALT and AST ≤5× ULN. * Urine protein ≤1+ by dipstick or 24-hour urine protein \<1 g/24 hours. Participants with 2+ proteinuria by dipstick must undergo 24-hour urine collection to assess urine protein level. * Creatinine creatinine clearance (CrCl) ≥30 mL/min per Cockcroft-Gault. * International normalized ratio (INR) and activated prothrombin time (aPTT) ≤1.5 ULN unless the participant is receiving anticoagulation therapy and INR and aPTT values are within the intended therapeutic range. * ECOG performance status (PS) of 0 or 1. * Age ≥ 18 years. * Women of child-bearing potential and men must agree to use ade…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT07136077

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Minimal Residual Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.