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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-10-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · Divsion of New Product Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Japan

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524498 on ClinicalTrials.gov