Status:
TERMINATED
Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 ...
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 as...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
888 Patients enrolled
Trial Details
Trial ID
NCT01465464
Start Date
December 1 2010
End Date
November 1 2014
Last Update
August 7 2019
Active Locations (6)
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1
Local Institution
Ōsaka-sayama, Osaka, Japan, 589-8511
2
Local Institution
Chuo-ku, Tokyo, Japan, 104-0045
3
Local Institution
Chiba, Japan, 260-8677
4
Local Institution
Goyang-si, Gyeonggi-do, South Korea, 410-769