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

August 5, 2019 updated by: Taiho Pharmaceutical Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

888

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8677
        • Local Institution
    • Osaka
      • Osaka-sayama, Osaka, Japan, 589-8511
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Local Institution
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Local Institution
  • Taiwan
      • Taipei, Taiwan, 100
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
1 tablet was administered orally twice per day after meals, morning and evening.
EXPERIMENTAL: Orantinib
Drug: Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 3, 2011

First Posted (ESTIMATE)

November 4, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Taiho132150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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