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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465464
Recruitment Status : Terminated
First Posted : November 4, 2011
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 1, 2011
First Posted Date  ICMJE November 4, 2011
Results First Submitted Date  ICMJE November 4, 2018
Results First Posted Date  ICMJE August 7, 2019
Last Update Posted Date August 7, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
Overall survival(OS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Time to Transcatheter Arterial Chemoembolization (TACE) Failure [ 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 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
Safety profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Orantinib
    Intervention: Drug: Orantinib (TSU-68)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Kudo M, Cheng AL, Park JW, Park JH, Liang PC, Hidaka H, Izumi N, Heo J, Lee YJ, Sheen IS, Chiu CF, Arioka H, Morita S, Arai Y. Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):37-46. doi: 10.1016/S2468-1253(17)30290-X. Epub 2017 Oct 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
888
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2011)
880
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01465464
Other Study ID Numbers  ICMJE Taiho132150
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Taiho Pharmaceutical Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Taiho Pharmaceutical Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Taiho Pharmaceutical Co., Ltd. Taiho Pharmaceutical Co., Ltd.
PRS Account Taiho Pharmaceutical Co., Ltd.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP