Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)
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|ClinicalTrials.gov Identifier: NCT01465464|
Recruitment Status : Terminated
First Posted : November 4, 2011
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Orantinib (TSU-68) Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||888 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||December 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||November 2014|
Drug: Orantinib (TSU-68)
200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
|Placebo Comparator: Placebo||
1 tablet was administered orally twice per day after meals, morning and evening.
- Overall survival(OS)
- Safety profile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465464
|Osaka-sayama, Osaka, Japan, 589-8511|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Chiba, Japan, 260-8677|
|Korea, Republic of|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|JongNo-Gu, Seoul, Korea, Republic of, 110-744|
|Zhongzheng Dist., Taipei, Taiwan, 100|
|Study Director:||Taiho Pharmaceutical Co., Ltd.||Taiho Pharmaceutical Co., Ltd.|