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
- Registration Number
- NCT00524498
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A OPC-18 FAIT B cisplatin BST
- Primary Outcome Measures
Name Time Method Antitumor effect (tumor size reduction) every 4 weeks
- Secondary Outcome Measures
Name Time Method Disease control rate Overall survival Progression-free survival every 4 weeks