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

Last updated: August 5, 2019
Sponsor: Taiho Pharmaceutical Co., Ltd.
Overall Status: Terminated

Phase

3

Condition

Hepatic Fibrosis

Digestive System Neoplasms

Liver Cancer

Treatment

N/A

Clinical Study ID

NCT01465464
Taiho132150
  • Ages > 20
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 888
Study Start date:
December 01, 2010
Estimated Completion Date:
November 30, 2014

Study 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.

Connect with a study center

  • Local Institution

    Osaka-sayama, Osaka 589-8511
    Japan

    Site Not Available

  • Local Institution

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Local Institution

    Chiba, 260-8677
    Japan

    Site Not Available

  • Local Institution

    Goyang-si, Gyeonggi-do 410-769
    Korea, Republic of

    Site Not Available

  • Local Institution

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Local Institution

    Taipei, 100
    Taiwan

    Site Not Available

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