Clinical trial NCT01465464: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 888
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival(OS)
timeFrame: 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:
measure: Time to Transcatheter Arterial Chemoembolization (TACE) Failure
timeFrame: 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
Other outcomes:
Locations:
city: Osaka-sayama
country: Japan
facility: Local Institution
state: Osaka
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chiba
country: Japan
facility: Local Institution
city: Goyang-si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References:
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.