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

Summary

A prospective, multicenter, randomized in a 2:1 ratio, controlled, clinical trial with two parallel arms will be conducted to compare irinotecan dose escalated FOLFIRI according to UGT1A1 genotyping plus 120 mg regorafenib with 120 mg regorafenib alone in previously treated patients with metastatic colorectal cancer (mCRC).

Timeline

Start

2019-02-26

Primary completion

2021-03-01

Completion

2021-12-31

Outcome

Met primary endpoint

paper The experimental group exhibited significant improvement in PFS (p = 0.016) PMID 41164204 ↗

Publications

• Huang CW, Chen YC, Ker TW, Lin YW, Chang TK, Su WC, Chen PJ, Tsai HL, Wang JY. Efficacy and safety of regorafenib plus FOLFIRI with UGT1A1 genotyping-guided irinotecan dose escalation against metastatic colorectal cancer: a multicenter, phase II, open-label, two-arm randomized controlled tria. Ther Adv Med Oncol. 2025 Oct 23;17:17588359251371489. doi: 10.1177/17588359251371489. eCollection 2025.
• Ma CJ, Chang TK, Tsai HL, Su WC, Huang CW, Yeh YS, Chang YT, Wang JY. Regorafenib plus FOLFIRI with irinotecan dose escalated according to uridine diphosphate glucuronosyltransferase 1A1genotyping in previous treated metastatic colorectal cancer patients:study protocol for a randomized controlled trial. Trials. 2019 Dec 19;20(1):751. doi: 10.1186/s13063-019-3917-z.

Drugs

Indications