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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524498
• Other study ID #: 018-06-002
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2007
• Last updated: October 13, 2015
• Start date: September 2007
• Est. completion date: January 2010

Study information

• Verified date: October 2015
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• OPC-18
OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
• cisplatin
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor effect (tumor size reduction)		every 4 weeks	Yes
Secondary	Disease control rate Overall survival Progression-free survival		every 4 weeks	Yes