A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

Otsuka

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: cisplatin; Drug: OPC-18

Study type: Interventional

Funder types: Industry

Identifiers

NCT00524498

018-06-002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
• Patients with a measurable lesion by contrast CT
• Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
• Patients who have not previously received intra-arterial hepatic chemotherapy

Exclusion criteria

• Patients receiving the herbal medicine shosaikoto
• Patients with autoimmune hepatitis
• Patients with a history of hypersensitivity to OPC-18 or other interferon preparations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A

Experimental group

Description:

FAIT

Treatment:

Drug: OPC-18

B

Active Comparator group

Description:

BST

Treatment:

Drug: cisplatin