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

• 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: Taiho Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Taiho Pharmaceutical Co., Ltd.

Tracking Information

• First Submitted Date: November 1, 2011
• First Posted Date: November 4, 2011
• Results First Submitted Date: November 4, 2018
• Results First Posted Date: August 7, 2019
• Last Update Posted Date: August 7, 2019
• Study Start Date: December 2010
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: November 3, 2011): Overall survival(OS)

Current Secondary Outcome Measures (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 (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: Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 20, 2014): 888
• Original Estimated Enrollment (submitted: November 3, 2011): 880
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Korea, Republic of, Taiwan

Administrative Information

• NCT Number: NCT01465464
• Other Study ID Numbers: Taiho132150
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taiho Pharmaceutical Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Taiho Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Taiho Pharmaceutical Co., Ltd.; Taiho Pharmaceutical Co., Ltd.

• PRS Account: Taiho Pharmaceutical Co., Ltd.
• Verification Date: August 2019