Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)

This clinical study evaluates the efficacy and safety of regorafenib in patients with advanced liver cancer who have progressed on sorafenib treatment.

Approximately 560 patients who meet the entry criteria will be randomly assigned in a 2:1 ratio to regorafenib or placebo (1/3 chance to receive placebo).

Primary endpoint of the study is overall survival.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib
Enrollment: 573
Study Start Date: May 2013
Estimated Study Completion Date: October 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Regorafenib
- Placebo Comparator: Placebo