Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Orantinib (TSU-68)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orantinib<br> | Drug: Orantinib (TSU-68)<br>* 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 tablet was administered orally twice per day after meals, morning and evening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Transcatheter Arterial Chemoembolization (TACE) Failure | 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 | 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 |