Phase II Trial of Balloon Occluded Transarterial Chemoembolization with Epirubicin and Ethiodized Oil for Large Advanced Hepatocellular Carcinomas of the Barcelona Clinic Liver Cancer Stage B
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000013870
- Lead Sponsor
- Department of Radiology, Juntendo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Not provided
1) Extrahepatic metastasis. 2) Diagnostic or suspicious lesion of Portal venous invasion, hepatic venous invasion or bile duct invasion. 3) Post ruputred state of hepatocellular carcinoma 4) Remarkable arterio-portal or arterio-venous shunting. 5) Hepatic artery occlusion or major extrahepatic collaterals interfering effective drug delivery. 6) Post biliary reconstruction state. 7) Refractory ascites or pleural effusion. 8) Comorbid diseases as cardiac failure, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders. 9) Fever (more than 38 degrees Celsius) 10) Allergy to contrast media or anthracycline agents. 11) Pregnant or lactating. 12) Other reasons not indicated to this study judged by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Frequency and levels of adverse effects, change of tumor markers, overall survival, 1-year survival rate, 2-year survival rate, progression free survival