Benefits of a combination of chemotherapy tablets and injectable targeted therapy versus using a targeted therapy tablet alone in colorectal cancer patients

Intervention1: Arm A TAS-102 plus Bevacizumab: Bevacizumab 5 mg per m2 IV over 60 mins q every 15 days subsequent administrations over 30 mins if the initial administration tolerated well
plus Tab TAS 102 35 mg per m2 twice daily on days 1to5 and 8 to 12 PO every 28 days
1 cycle Start of next cycle on D 29
Control Intervention1: Arm B Regorafenib: Tab Regorafenib 80 mg PO OD 3 weeks on 1 week off q 28 days
1 cycle
Regorafenib dosing will be escalated by 40mg every cycle if there is no grade 3 or grade 4 Regorafenib related adverse events in the prior cycle
Primary outcome(s): To evaluate the difference in overall survival (OS) at 6 months between
TAS102-Bevacizumab combination and Regorafenib.
Timepoint: 53 months
Study Design: Other Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label