Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma Neoplasms Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 954
Healthy volunteers: no

Brief summary:
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

Detailed description:

Arms:
arm 1: Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. arm 2: Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Interventions: intervention 1: Lenvatinib intervention 2: Sorafenib
Intervention descriptions: intervention 1: 12 mg (or 8 mg) once daily (QD) oral dosing. intervention 2: 400 mg twice daily (BID) oral dosing.

Protocol document: