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Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer
NCT07136077Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2025
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Fragment-Derived Small Molecules, Monoclonal Antibodies, Allosteric Modulators
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of fruquintinib and tislelizumab in colorectal cancer (CRC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: ctDNA clearance rate at 6 months and Safety and adverse events (AEs) at 1 year. Started Sep 2025; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Phase II: Treatment with Fruquintinib and Tislelizumab
Participants receive Fruquintinib and Tislelizumab.
03
Who it enrols
Adults with MSS colorectal adenocarcinoma who completed curative intent treatments including >=3 months of oxaliplatin-containing chemotherapy, have positive ctDNA (MRD) without radiographic disease, adequate organ function, and ECOG PS 0-1.
04
Endpoints
Primary
ctDNA clearance rate
Safety and adverse events (AEs)
Secondary
ctDNA clearance rate
Disease-Free Survival
Overall Survival
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