Trials / Completed
CompletedNCT00524498
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPC-18 | OPC-18: 500IU \* 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery |
| DRUG | cisplatin | infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2007-09-03
- Last updated
- 2015-10-15
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00524498. Inclusion in this directory is not an endorsement.