At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 573 enrolled
Drug / intervention
Regorafenib (Stivarga, BAY73-4506) +1 moredrug
Likely dose
Regorafenib (Stivarga, BAY73-4506) 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib
In Brief
A Phase 3 clinical trial evaluating Regorafenib (Stivarga, BAY73-4506) and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 573 participants across 147 sites in 21 countries.
Detailed Summary
The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesArgentina, Australia, Austria, Belgium, Brazil, China, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartMay 2013
Primary CompletionFeb 2016
Study CompletionJul 2019
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartMay 14, 2013
Primary CompletionFeb 29, 2016
Study CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.4 years ago
Interventions
Regorafenib (Stivarga, BAY73-4506)drug
Regorafenib, 40 mg tablets
Placebodrug
Placebo tablets matching in appearance