Hepatocellular carcinoma
Conditions
Interventions
Transarterial chemoembolization using cisplatin (CDDP-TACE), Liver resection
Sponsors
Multicenter Clinical Study Group of Osaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinical diagnosed hepatocellular carcinoma 2) A proper indication for TACE without indication of surgery or ablation therapy 3) 20 years old and more 4) Performance status (ECOG) 0 or 1 5) life expectantcy of at least 6 months 6) Child-pugh A or B 7) Satisfying following blood test before registration WBC >=2,000/micro litter Neu >=1,000/micro litter Hb >= 8.5g/dL Platelet >=70,000 /micro litter Total bilirubin <=1.5 mg/dl AST [GOT] <= 150 IU/L ALT [GPT] <= 150 IU/L Creatinine <= 1.2 mg/dL 8) Primary cases or recurrence cases after hepatectomy or RFA 9) Agreement to be enrolled in a form of informed consent
Exclusion criteria
Exclusion criteria: 1) Patologically diagnosed as combined hepatocellular and cholangiocellular carcinoma 2) Extrahepatic metastasis 3) Vascular involvement Vp3 or more 4) Hepatic encephalopathy 5) Active infection except for HBV and HCV 6) Severee complications 7) acitve double cancer 8) Pregnant, possibility of pregnancy, or feeding a baby Pregnancy 9) Medication that may affect to the absorption of drug or pharmacokinetics 10) Other factors that a responsible doctor judged to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate for salvage surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate for TACE, Time to progression (TTP), Overall survival (OS), disease-free survival time after salvage hepatectomy, completion rate, safty & adverse event | — |
Countries
Japan
Contacts
Public ContactHiroshi Wada
Graduate School of Medicine, Osaka University Department of Surgery
Outcome results
None listed