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
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
|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) [ Time Frame: 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 ]
- Time to Transcatheter Arterial Chemoembolization (TACE) Failure [ Time Frame: 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 ]
Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.
- The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE
- Deterioration in arterial pathways to treat HCC that makes additional TACE impossible
- Severe vascular invasion occurs that makes additional TACE impossible
- Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC
- Liver function at grade Child-Pugh class C lasting for 28 days
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|
|Seoul, Korea, Republic of, 110-744|
|Taipei, Taiwan, 100|
|Study Director:||Taiho Pharmaceutical Co., Ltd.||Taiho Pharmaceutical Co., Ltd.|