To compare the overall survival of patients with advanced HCC receiving axitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
Patients will be randomized (2:1 ratio) to receive either axitinib + BSC (Arm A) or placebo + BSC (Arm B).
Axitinib or placebo will be administered, twice daily (BID) on a continuous daily dosing schedule.
The primary objective is to compare the overall survival (OS; time from randomization to death) in patients with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent. Patients will receive either ramucirumab (IMC-1121B) drug product (hereafter referred to as ramucirumab DP) plus best supportive care (BSC) or placebo plus BSC.
1:1 randomization of IV ramucirumab/placebo infusion every 2 weeks. A treatment cycle will be defined as 2 weeks, with radiologic evaluation every 6 weeks (± 3 days) after first dose of study therapy for the first 6 months, and every 9 weeks (± 3 days) thereafter.
To evaluate current staging system for patients with hepatocellular carcinoma (HCC) and evaluate if new blood tests at the time of HCC diagnosis improves the accuracy of predicting outcomes of patients with liver cancer.
To evaluate the usefulness of new markers found in blood that might help to diagnose of hepatocellular carcinoma (HCC) early among people with cirrhosis. If we can establish new tumor markers for the detection of this tumor at early stage, which are currently lacking, this information could be applied to patients at the highest risk of HCC. We plan to store blood for this and future studies that may lead to better tests for the early detection of HCC.