Hepatocellular Carcinoma
Conditions
Keywords
OPC-18, Interferon-alpha, Fluorouracil
Brief 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.
Interventions
DRUGOPC-18
OPC-18: 500IU \* 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery
DRUGcisplatin
infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antitumor effect (tumor size reduction) | every 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate Overall survival Progression-free survival | every 4 weeks |
Countries
Japan
Outcome results
None listed