advanced hepatocellular carcinoma
Conditions
Interventions
FMP therapy: The therapy consists of intraarterial administration of cisplatin and mitoxantrone on day 1, and continuous intraarterial infusion of 5-fluorouracil on days 1 through 5. The treatment i
Sponsors
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Advanced hepatocellular carcinoma with confirmation of histological examination or typical computed tomographic(CT), angiographic findings and elevated serum alpha-fetoprotein levels 2) No indication for surgical resection, local ablation, and transcatheter arterial embolization 3) Measurable disease 4) Aged 20 years or over 5) An Eastern Cooperative Oncology Group performance status of 0-2 6) A hepatic arterial catheter and port system placed and the adequate drug distribution confirmed by CT angiography or MR angiography 7) Sufficient organ function: WBC>=3,000 /mm3, Hb>=9.0 g/dL, PLT>=70,000 /mm3, Child-Pugh grade A or B, T-Bil<=2.0 mg/dL, Albumin>=3.0 g/dL, AST<=200 U/L, ALT<=200 U/L, Creatinine<=1.1 mg/dL, Creatinine clearance>= 60 ml/min 8) Interval of 4 weeks or over between last treatment and present therapy, and no influence of previous treatments 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior chemotherapy with 5-fluorouracil, mitoxantrone, and cisplatin for hepatocellular carcinoma 2) Refractory pleural effusion or ascites 3) Allergic reaction to iodine contrast material 4) Severe heart disease 5) Active infection excluding hepatitis B or C viral infection 6) Active concomitant malignancy 7) Severe mental disorder 8) Severe allergic reaction to drug 9) Severe complication 10) Pregnant and lactating females; females of childbearing age unless using effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: frequency of dose-limiting toxicities Phase II: response rate and adverse events at the recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactMasafumi Ikeda, MD.
FMP HAI Coordinating Office Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Outcome results
None listed