Regorafenib and XELOX as 2nd Line Treatment in Metastatic Colorectal Cancer

This is a phase Ib/II trial, comprising Phase Ib and Phase II two parts. Phase Ib study is an open‐label, single‐arm, multicenter, dose escalation study of Regorafenib plus XELOX. In Phase Ib, max 15 patients(pts) could be enrolled based on the modified toxicity probability interval (mTPI) design. Phase II study is a randomized, open‐label, parallel‐group, multicenter study comparing Regorafenib + XELOX to XELOX alone. In phase II trial, a total of 39 patients will be recruited and randomized 2:1 into two groups, where 26 patients under Regorafenib + XELOX, and 13 patients under XELOX alone.