This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.
Approximately 544 patients will be randomized and will be at least 18 years of age with HCC. Patients must have received sorafenib as first-line systemic treatment for HCC, and must have discontinued sorafenib prior to entering the study.
Hypothesis: This sample size will allow differentiation of the expected increase in median OS, from 6 months in the placebo arm to 8 months with the addition of ramucirumab).
Upon registration and completion of screening procedures, eligible patients with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.
The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the patient, or investigator decision.