hepatocellular carcinoma
Conditions
Interventions
hepatic arterial infusion chemotherapy. 5-FU 300mg/m2, day 1 to 5, 5 to 19. CDDP 45mg/m2, 55mg/m2 or 65mg/m2, day2. 1 course = 28 days. continue till PD.
Sponsors
Sapporo Medical University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were considered eligible for this study based on following criteria: advanced unresectable hepatocellular carcinoma; clinical stage III or IVA; no prior chemotherapy or radiation therapy within one month; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; age; 18 years; adequate baseline bone marrow function (hemoglobin level>9g/dl, neutrophil count>1,500/mm3 and platelet count >70,000/mm3) ; adequate hepatic function (total bilirubin level;2.0 mg/dl, aspartate aminotransferase and alanine aminotransferase levels five times the upper limit of normal); adequate renal function (serum creatinine level1.5 mg/dl); adequate respiratory and cardiac function; no metastatic lesion except for liver; and life expectancy at least three months. Written informed consent was obtained from all patients.
Exclusion criteria
Exclusion criteria: complete obstruction of either celiac artery, common hepatic artery or splenic artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy | — |
Countries
Japan
Contacts
Public ContactKoji Miyanishi
Sapporo Medical University School of Medicine Dept. of Oncology and hematology
Outcome results
None listed