Abstract

The phase 3 clinical trial of the novel multikinase inhibitor lenvatinib for patients with advanced HCC (REFLECT trial) showed that its overall survival (OS) is non-inferior to and the progression-free survival (PFS) is significantly longer than that of sorafenib. However, data on the safety and efficacy of lenvatinib for patients with unresectable HCC who did not met the REFLECT inclusion criteria are limited. In the REFLECT trial, patients were excluded if they had history of multikinase inhibitor treatment, had HCC involving ≥50% of the liver, main portal vein invasion, Child-Pugh grade B, platelet count 9 /l, or obvious bile duct invasion; thus, the efficacy and safety of lenvatinib for such patients have not been clarified.

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