A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
M.D. Anderson Cancer Center
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).
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 fol…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria * Participants must have histologically or cytologically confirmed microsatellite stable (MSS) colorectal adenocarcinoma. * Participants must have completed curative intent treatments of stages II, III, or IV colorectal cancer that must include ≥ 3 months of oxaliplatin containing chemotherapy. * No evidence of radiographic disease within 28 days (before or after) a positive ctDNA assay. * Participants must have minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson) such as Signatera. Participants may be identified for e…
Interventions
- DrugTislelizumab
Given by IV
- DrugFruquintinib
Give by PO
Location
- MD Anderson Cancer CenterHouston, Texas