NCT01465464

Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 888 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Orantinib (TSU-68)	200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
DRUG	Placebo	1 tablet was administered orally twice per day after meals, morning and evening.

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2011-11-04
• Last updated: 2019-08-07
• Results posted: 2019-08-07

Locations

6 sites across 3 countries: Japan, South Korea, Taiwan