search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Orantinib (TSU-68)
Placebo
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orantinib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival(OS)

Secondary Outcome Measures

Time to Transcatheter Arterial Chemoembolization (TACE) Failure
Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE Deterioration in arterial pathways to treat HCC that makes additional TACE impossible Severe vascular invasion occurs that makes additional TACE impossible Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC Liver function at grade Child-Pugh class C lasting for 28 days

Full Information

First Posted
November 1, 2011
Last Updated
August 5, 2019
Sponsor
Taiho Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01465464
Brief Title
Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
Acronym
ORIENTAL
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
888 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orantinib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Orantinib (TSU-68)
Intervention Description
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet was administered orally twice per day after meals, morning and evening.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time to Transcatheter Arterial Chemoembolization (TACE) Failure
Description
Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE Deterioration in arterial pathways to treat HCC that makes additional TACE impossible Severe vascular invasion occurs that makes additional TACE impossible Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC Liver function at grade Child-Pugh class C lasting for 28 days
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiho Pharmaceutical Co., Ltd.
Organizational Affiliation
Taiho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Local Institution
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28988687
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs