Conditions: Hepatocellular Carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 888
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the overall survival (OS) for Orantinib in combination with transcatheter arterial chemoembolization (TACE) versus placebo in combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).

Detailed description:
This is a randomized, multi-center, double-blind, placebo-controlled phase III trial of Orantinib administered in combination with TACE in patients with unresectable HCC.

Patients will be randomly assigned (1:1) to receive TACE given in combination with either Orantinib (200 mg orally, twice per day) or placebo.

ORIENTAL:ORantinib InvEstigatioN on TAce combination triaL.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Orantinib (TSU-68) intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening. intervention 2: 1 tablet was administered orally twice per day after meals, morning and evening.

Protocol document: