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.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Drug: Orantinib (TSU-68); Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 888 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: December 2010
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

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

Seoul, Korea, Republic of, 110-744

Taiwan

Local Institution

Taipei, Taiwan, 100

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01465464
• Other Study ID Numbers: Taiho132150
• First Posted: November 4, 2011
• Results First Posted: August 7, 2019
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Orantinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action