A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Trial Parameters
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).
Eligibility Criteria
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 enrollment and followed with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count of ≥1.0×109/L * Platelet count of ≥100×109/L * Hemoglobin ≥9 g/dL * Serum total bilirubin ≤1.5× upper limit of normal (ULN) (total bilirubin must be \<3× ULN for participants with doc