A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
20 Years
N/A
Both
Hepatocellular Carcinoma
Trial Information
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Overall survival(OS)
Principal Investigator
Taiho Pharmaceutical Co., Ltd.
Investigator Role:
Study Director
Investigator Affiliation:
Taiho Pharmaceutical Co., Ltd.
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
Taiho132150
NCT ID:
NCT01465464
Start Date:
December 2010
Completion Date:
May 2017
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma
- Carcinoma, Hepatocellular
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