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

NCT01465464 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 888

Last updated 2019-08-07

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taiho Pharmaceutical Co., Ltd. · Taiho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-06-30
Completion
2014-11-30

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01465464 on ClinicalTrials.gov