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No established regimens exist for the treatment of patients with advanced hepatocellular carcinoma after failure of first-line treatment with the multikinase inhibitor sorafenib. Outcomes in the setting of sorafenib resistance or intolerance are poor, with a median expected overall survival for the placebo arms of second-line trials in the range of 7 to 8 months.

In recent years, knowledge of hepatocellular carcinoma (HCC)-specific tumor-associated antigens and the development of immune checkpoint blockade therapy has offered a positive outlook for patients with HCC.