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

Hepatocellular Carcinoma Clinical Trial

— ORIENTAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465464
• Other study ID #: Taiho132150
• Status: Terminated
• Phase: Phase 3
• Start date: December 2010
• Est. completion date: November 2014

Study information

• Verified date: August 2019
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 888
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients must be diagnosed as HCC.

• Patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

• Patients are able to receive oral medication.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
• Placebo
1 tablet was administered orally twice per day after meals, morning and evening.

Locations

Country	Name	City	State
Japan	Local Institution	Chiba
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Osaka-sayama	Osaka
Korea, Republic of	Local Institution	Goyang-si	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Taiwan	Local Institution	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival(OS)		The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient
Secondary	Time to Transcatheter Arterial Chemoembolization (TACE) Failure	Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.; The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE; Deterioration in arterial pathways to treat HCC that makes additional TACE impossible; Severe vascular invasion occurs that makes additional TACE impossible; Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC; Liver function at grade Child-Pugh class C lasting for 28 days	The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient