hepatocellular carcinoma
Conditions
Interventions
Patients with unresectable HCC undergo TACE using an emulsion of epirubicin HCl or doxorubicin HCl and Lipiodol, followed by injection of gelatin sponge particles. The same treatment is repeated if th
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Korea Interventional Radiology in Oncology Study Group (KIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically diagnosed HCC (excluding the mixed type) 2) No previous treatment for HCC 3) No indication for hepatic resection, liver transplantation or local ablative therapy (radiofrequency ablation, etc.) 4) Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection 5) No tumor thrombus in the first branch or main portal vein 6) Eastern Cooperative Oncology Group performance status of 0 to 2 7) Child-Pugh classification of A or B 8) Adequate hematologic, hepatic, renal, and cardiac function; laboratory tests within two weeks before registration in the study are defined as: (1) WBC : >= 3,000/mm2 (2) Platelet count : >=50,000/mm3 (3) Serum bilirubin : <=3.0 mg/dL 9) Patient age 20 years and above 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Extrahepatic metastasis 2) Hepatic vein invasion or biliary invasion 3) Ruptured tumor 4) Prior surgical reconstruction or endoscopic treatment of the biliary tract 5) Clinically significant refractory ascites or pleural effusion 6) Severe arterio-portal or arterio-venous shunts in the liver 7) Allergy to contrast medium that precludes angiography 8) Severe, active co-morbidity, defined as follows: - Uncontrolled cardiac failure, angina and/or rhythm disorders - Myocardial infarction within the last 6 months - Renal failure - Active infection (viral hepatitis is allowed) - Active gastrointestinal bleeding - Other active malignant tumor - Hepatic encephalopathy or severe mental disorder 9) Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception 10) Not eligible because of safety issues judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence and grade of adverse events, response rate | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactMasafumi Ikeda
National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed