A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer

Exclusion criteria

• ✕. Patients with known MSI-high or mismatch repair deficient (dMMR) status or in whom the status of both are unknown
• ✕. Patients with BRAF V600 mutations
• ✕. Prior treatment with regorafenib, trifluridine-tipiracil (TAS-102), or fruquintinib.
• ✕. Major surgery within 14 days of C1D1. Minor procedures (e.g. biopsies, central venous catheters) are not considered major surgery.
• ✕. Patients must have recovered from clinically significant AEs of their most recent prior therapy/intervention prior to enrollment as determined by relevant clinical and laboratory parameters.
• ✕. Untreated CNS metastases or known leptomeningeal disease. Patients with treated CNS metastases (either by surgical or radiation techniques) are eligible provided there is no evidence of progression for at least 4 weeks after CNS-directed therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
• ✕. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
• ✕. Uncontrolled intercurrent illness (defined as but not limited to others in the opinion of the treating investigator):