Fruquintinib Combined With Trifluridine/Tipiracil Versus Bevacizumab Combined With Trifluridine/Tipiracil for Advanced Metastatic Colorectal Cancer

Phase II study comprises a safety run-in stage, and a randomized treatment stage. Phase II (safety run-in stage): It aims to evaluate the safety and tolerability of combination therapy-comprising trifluridine/tipiracil and fruquintinib. Trifluridine/tipiracil was administered at a descending dose level starting from 35 mg/m² each time alongside fixed dose of fruquintinib in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Phase II (randomized treatment stage): Upon determination of the recommend dose of trifluridine/tipiracil based on prior data, a randomized controlled study will be conducted in mCRC patients who have previously received first-line oxaliplatin and irinotecan-based therapy, or have failed at least two lines of standard chemotherapy regimens. Patients will be randomly assigned to two arms: experimental arm: Fruquintinib and trifluridine/tipiracil; active comparator arm: Bevacizumab and trifluridine/tipiracil.