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drugset / Trial / NCT00524498

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

NCT00524498 ↗

Phase 2 Completed 60 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-09
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 10 mg Other
Subject OPC-18 Unknown 500 iu Subcutaneous
Subject fluorouracil Small molecule 250 mg Other
Subject fluorouracil Small molecule 500 mg Other

Indications

hepatocellular carcinoma