NCT07136077

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tislelizumab	Given by IV
DRUG	Fruquintinib	Give by PO

Timeline

• Start date: 2025-09-18
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2025-08-22
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study