Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated in Patients With Previously Treated Metastatic Colorectal Cancer

Primary objective: Progression-free survival Secondary objective: Overall survival, best objective response, disease control rate, time to progression, duration of treatment and adverse events Number of Subjects: 153 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting. Plan of the Study: 1. This is a prospective, multicenter, randomized in a 2:1 ratio, controlled study. 2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 4 years. 3. Duration of Treatment: Treatment was administered until disease progressed.