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

Running, not enrolling · Phase 2

Conditions studied: Minimal Residual Disease, Adjuvant Chemotherapy, Colorectal Cancer, Fruquintinib, Tislelizumab, ctDNA

In brief

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).

Key facts

Study ID

NCT07136077

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2025-09-18

Expected to finish

2028-04-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed).
• Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment.
• Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study.
• Active autoimmune diseases or history of autoimmune diseases that may worsen or relapse per treating providers' evaluation.
• Has a persistent adverse event from previous treatment, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0
• Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy.
• Systemic small molecule-targeted therapies (eg, tyrosine kinase inhibitors) within 5 halflives or 4 weeks (whichever is shorter) prior to the first dose of study drug.
• Mean QT interval corrected by the method of Fridericia (QTcF) ≥480 ms.
• Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the participant at undue risk of harm
• Has known hypersensitivity to the trial drugs or their excipients or is at risk of allergic of anaphylactic reaction to drug product according to the Investigator's judgement.
• Is pregnant or lactating.
• Is unable to take medication orally or has any other condition that investigators believe may affect absorption of the investigational product.
• Is receiving any other investigational agent.
• Any condition that requires systemic treatment with either corticosteroid (>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first dose of study drug(s), with the following exceptions:
• Adrenal replacement (dose of ≤10 mg daily of prednisone or equivalent).
• Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
• Short course (≤7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
• Live vaccine ≤28 days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
• Known untreated or inadequately treated active hepatitis C, or chronic hepatitis B.
• Known untreated or inadequately treated human immunodeficiency virus (HIV) infection.
• Major surgery within 30 days before the first drug administration. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s).
• Prior allogeneic stem cell transplantation or organ transplantation.
• Any of the following cardiovascular risk factors:
• Acute myocardial infarction ≤6 months before the first dose of study drug(s).
• Heart failure meeting New York Heart Association Function Classification III or IV ≤6 months before the first dose of study drug(s)

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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