Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)

This study has been terminated.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd. Identifier:
First received: November 1, 2011
Last updated: November 20, 2014
Last verified: November 2014

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).

Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Orantinib (TSU-68)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall survival(OS)

Secondary Outcome Measures:
  • Safety profile

Enrollment: 888
Study Start Date: December 2010
Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Orantinib Drug: Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
Placebo Comparator: Placebo Drug: Placebo
1 tablet was administered orally twice per day after meals, morning and evening.

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.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01465464

Local Institution
Osaka-sayama, Osaka, Japan, 589-8511
Local Institution
Chuo-ku, Tokyo, Japan, 104-0045
Local Institution
Chiba, Japan, 260-8677
Korea, Republic of
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Local Institution
JongNo-Gu, Seoul, Korea, Republic of, 110-744
Local Institution
Zhongzheng Dist., Taipei, Taiwan, 100
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Study Director: Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT01465464     History of Changes
Other Study ID Numbers: Taiho132150
Study First Received: November 1, 2011
Last Updated: November 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on February 27, 2015