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

Not Applicable

Not yet recruiting

• Conditions: Minimal Residual Disease; Adjuvant Chemotherapy; Colorectal Cancer; Fruquintinib; Tislelizumab; ctDNA
• Interventions: Drug: Tislelizumab; Drug: Fruquintinib

• Registration Number: NCT07136077
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2026-02-05
• Primary Completion: 2026-04-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase II: Treatment with Fruquintinib and Tislelizumab	Tislelizumab	Treatment with Fruquintinib and Tislelizumab
Phase II: Treatment with Fruquintinib and Tislelizumab	Fruquintinib	Treatment with Fruquintinib and Tislelizumab

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States