Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)

Taiho Pharma

Status and phase: Terminated; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Placebo; Drug: Orantinib (TSU-68)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465464

Taiho132150

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 888 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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888 participants in 2 patient groups, including a placebo group

Orantinib

Experimental group

Treatment:

Drug: Orantinib (TSU-68)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo