Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial

•This double-blind, randomized phase II trial evaluated regorafenib versus placebo in pretreated biliary tract cancer patients.•Regorafenib significantly increased mPFS versus placebo, from 1.5 to 3.0 months (P = 0.004).•Regorafenib significantly increased tumor control.•There were no new or unexpected safety signals. BackgroundThere is a high unmet clinical need for treatments of advanced/metastatic biliary tract cancers after progression on...