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

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

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.

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