Hepatocellular carcinoma
Conditions
Interventions
arterial embolization with drug eluting beads
Sponsors
Japan Interventional Radiology In Oncology Study Group(IVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically diagnosed HCC (excluding the mixed type) 2) No indication for hepatic resection, liver transplantation or local ablative therapy (radiofrequency ablation, etc.) 3) Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection 4) No tumor thrombus in the first branch or main portal vein 5) Eastern Cooperative Oncology Group performance status of 0 to 2 6) Child-Pugh classification of A or B 7) Adequate hematologic, hepatic, renal, and cardiac function; laboratory tests within two weeks before registration in the study are defined as: (1) WBC (2) Platelet count (3) Serum bilirubin 8) Patient age 20 years and above 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Prior surgical reconstruction or endoscopic treatment of the biliary tract 2) Clinically significant refractory ascites or pleural effusion 3) Severe arterio-portal or arterio-venous shunts in the liver 4) Allergy to contrast medium that precludes angiography 5) 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 6) 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 7) Not eligible because of safety issues judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactHiroaki Ishii
National Cancer Center Hospital Department of Diagnostic Radiology
Outcome results
None listed