NCT01465464

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
888

participants targeted

Target at P75+ for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2010

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

August 7, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

November 1, 2011

Results QC Date

November 4, 2018

Last Update Submit

August 5, 2019

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival(OS)

    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 Outcomes (1)

  • Time to Transcatheter Arterial Chemoembolization (TACE) Failure

    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

Study Arms (2)

Orantinib

EXPERIMENTAL
Drug: Orantinib (TSU-68)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Orantinib (TSU-68)DRUG

200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.

Orantinib
PlaceboDRUG

1 tablet was administered orally twice per day after meals, morning and evening.

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Local Institution

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution

Chiba, 260-8677, Japan

Location

Local Institution

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Local Institution

Seoul, 110-744, South Korea

Location

Local Institution

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 28988687DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

orantinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Taiho Pharmaceutical Co., Ltd.
Organization
Clinical Trial Registration Contact
toiawase@taiho.co.jp

Study Officials

  • Taiho Pharmaceutical Co., Ltd.

    Taiho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

August 7, 2019

Results First Posted

August 7, 2019

Record last verified: 2019-08

Locations

KR(2)TW(1)JP(3)