Metastatic Colorectal Cancer Clinical Trial
Official title:
Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated According to UGT1A1 Genotyping Versus Regorafenib Monotherapy in Patients With Previously Treated Metastatic Colorectal Cancer: A Prospective, Randomized, Controlled Study
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).
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.
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