At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,114 enrolled
Drug / intervention
Nexavar (Sorafenib, BAY43-9006) +1 moredrug
Likely dose
Nexavar (Sorafenib, BAY43-9006) 400 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 Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.
In Brief
A Phase 3 clinical trial evaluating Nexavar (Sorafenib, BAY43-9006) and Placebo for Carcinoma, Hepatocellular. Completed, enrolled 1,114 participants across 199 sites in 28 countries.
Detailed Summary
To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, New Zealand, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2008
Enrollment StartAug 2008
Primary CompletionNov 2013
Study CompletionNov 2014
TodayJul 2026
First PostedJun 6, 2008
Enrollment StartAug 15, 2008
Primary CompletionNov 29, 2013
Study CompletionNov 28, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.1 years ago
Interventions
Nexavar (Sorafenib, BAY43-9006)drug
Sorafenib 400 mg twice daily (BID)
Placebodrug
Placebo 2 tablets twice daily (BID)