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

Phase 3

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Orantinib (TSU-68); Drug: Placebo

• Registration Number: NCT01465464
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Primary Completion: 2014-06
• Study Completion: 2014-11
• Results First Submitted: 2018-11-04
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-05
• Last Update Submitted: 2019-08-05
• Results First Posted: 2019-08-07
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 888

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orantinib	Orantinib (TSU-68)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to Transcatheter Arterial Chemoembolization (TACE) Failure	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	Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.; 1. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE; 2. Deterioration in arterial pathways to treat HCC that makes additional TACE impossible; 3. Severe vascular invasion occurs that makes additional TACE impossible; 4. Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC; 5. Liver function at grade Child-Pugh class C lasting for 28 days

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taipei, Taiwan