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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPC-18

Drug

OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery

Cisplatin

Drug

infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day

Other names: low-dose FP treatment

Primary outcomes

Antitumor effect (tumor size reduction)

Time frame: every 4 weeks

Secondary outcomes

Disease control rate Overall survival Progression-free survival

Time frame: every 4 weeks

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Sep 3, 2007
Registry last updated: Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed