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
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Antitumor effect (tumor size reduction)
Outcome Time Frame:
every 4 weeks
Safety Issue:
Yes
Principal Investigator
Katsuhisa Saito
Investigator Role:
Study Director
Investigator Affiliation:
Divsion of New Product Development
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
018-06-002
NCT ID:
NCT00524498
Start Date:
September 2007
Completion Date:
January 2010
Related Keywords:
- Hepatocellular Carcinoma
- OPC-18
- Interferon-alpha
- Fluorouracil
- Carcinoma
- Carcinoma, Hepatocellular
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