At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 399 enrolled
Drug / intervention
Ramucirumab +1 moredrug
Likely dose
Not stated in 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.
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
In Brief
A Phase 3 clinical trial evaluating Ramucirumab and Placebo for Hepatocellular Carcinoma. Completed, enrolled 399 participants across 131 sites in 20 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment \[MEE\] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJul 2015
Primary CompletionMar 2018
Study CompletionNov 2021
TodayJul 2026
First PostedMay 6, 2015
Enrollment StartJul 20, 2015
Primary CompletionMar 15, 2018
Study CompletionNov 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.2 years ago
Interventions
Ramucirumabdrug
Administered IV
Placebodrug
Administered IV