Expanded Treatment Efficacy and Safety Study of Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma with Epirubicin/ Doxorubicin-Lipiodol Emulsion and Gelatin Particles: Korea-Japan Cooperative Study (JIVROSG-0604)
- Conditions
- hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000000975
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year survival rate
- Secondary Outcome Measures
Name Time Method incidence and grade of adverse events, response rate