Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Treatment-naive hepatocellular carcionma 2) Five or fewer tumors, At least one tumor has 5 cm or lager to 10 cm or less in maximum diameter 3) No invasion to veins and biliary duct 4) Child-Pugh score <= 8 5) Liver tumor seems to be the most important factor of prognosis 6) No candidate for surgery or ablation therapy 7) Function of liver, kidney, and bone marrow are normal 8) Over 20 years old 9) ECOG performance status: 0 or 1 10) Expected survival time over 12 weeks 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of the surgery or endoscopic treatment of the biliary duct 2) Sever arterioportal shunt or arteriovenous shunt 3) Sever stenosis or occlusion of the hepatic artery 4) History of rupture of hepatocellular carcionma 5) Treatment refractory pleural effusion or ascites 6) Sever complication: heart failure, angina pectoris, arrhythmia myocardial infarction duplicate active cancer active infection active gastrointestinal hemorrhage hepatic encephalopathy, mental disorder iodine allergy, sever drug allergy 7) Pregnant woman or woman who want to be pregnant 8) Qualified ineligible patients being this clinical trial by responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of large hepatocellular carcinoma (3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Response rate of all hepatocellular carcinomas, Progression free survival, Survival rate (1-year), Overall survival rate, Hospital stay | — |
Countries
Japan
Contacts
Public ContactMasashi Fujimori
Mie University School of Medicine Radiology
Outcome results
None listed