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

NCT ID: NCT07136077

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2028-04-01

Brief 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).

Detailed Description

Primary Objectives

• To determine the ctDNA clearance rate at 6 months in colorectal cancer participants with minimal residual disease following Fruquintinib and Tislelizumab therapy.

Secondary Objectives

• To determine the 3-month ctDNA clearance rates in colorectal cancer participants with minimal residual disease.
• To determine the disease-free survival (DFS) amongst colorectal cancer participants with minimal residual disease following Fruquintinib and Tislelizumab therapy.
• To determine the overall survival (OS) amongst colorectal cancer participants with minimal residual disease following Fruquintinib and Tislelizumab.
• To determine the safety and tolerability of Fruquintinib and Tislelizumab for the treatment of colorectal cancer participants with minimal residual disease.

Conditions

Minimal Residual Disease; Adjuvant Chemotherapy; Colorectal Cancer; Fruquintinib; Tislelizumab; ctDNA

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase II: Treatment with Fruquintinib and Tislelizumab

Treatment with Fruquintinib and Tislelizumab

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Given by IV

Fruquintinib

Intervention Type: DRUG

Give by PO

Interventions

Tislelizumab

Given by IV

Intervention Type: DRUG

Fruquintinib

Give by PO

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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)
• Ventricular arrhythmia Grade ≥2 in severity ≤6 months before the first dose of study drug(s).
• Cerebrovascular accident ≤12 months before the first dose of study drug(s).
• Uncontrolled hypertension that cannot be managed by standard antihypertension medications, which is specified as systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg. The participant must have blood pressures below both limits. Repeated assessments are permitted.
• Syncope or seizure ≤28 days before the first dose of study drug(s).
• Received strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) taken within 2 weeks (or 5 times the t1/2 of the drug, whichever is longer) prior to the first study treatment.
• Active gastrointestinal and duodenal ulcers, ulcerative colitis, and other gastrointestinal disease: other conditions that the investigator determines to possibly cause gastrointestinal bleeding, perforation, and other conditions; or prior gastrointestinal perforation or gastrointestinal fistula that has not recovered after surgical treatment.
• History or presence of clinically significant hemorrhage from any site (such as clinically significant melena, hematemesis, hemoptysis, fresh in stool) within 2 months before the screening.
• History of arterial thrombus within the last 12 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: collaborator

Takeda Pharmaceutical Co. Limited

UNKNOWN

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arvind Dasari, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2025-06047

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0696

Identifier Type: -

Identifier Source: org_study_id