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

Phase 3TerminatedNCT01465464

Taiho Pharmaceutical Co., Ltd.888 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

888

Conditions

Hepatocellular Carcinoma

Interventions

Orantinib (TSU-68)DRUG

200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.

PlaceboDRUG

1 tablet was administered orally twice per day after meals, morning and evening.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (6)

Local Institution

Ōsaka-sayama, Osaka, Japan

Local Institution

Chuo-ku, Tokyo, Japan

Local Institution

Chiba, Japan

Local Institution

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Overall Survival(OS)

Time frame: 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 Outcomes

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. 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

Time frame: 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

Data from ClinicalTrials.gov

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