Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- JPRN-UMIN000001384
- Lead Sponsor
- ACE 500 Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 450
Not provided
1. Subject has extra hepatic metastasis. 2. Tumor thrombosis exists at main portal vein. 3. Remarkable artery-portal vein shunt or veno-arterial shunt. 4. Uncontrollable ascites or pleural effusion. 5. History of severe hypersensitivity. 6. Any previous TACE or TAE for HCC. 7. Any previous chemotherapy using epirubicin or CDDP. 8. Complications as below (except chronic hepatitis or liver cirrhosis) 1) Severe heart disease 2) Myocardial infarction within 6 months 3) Renal insufficiency 4) Active infections (except virous hepatitis) 5) Gastrointestinal bleeding 6) Active double cancer 7) Hepatic encephalopathy or heavy mental disorder. 9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. 10. Any subject judged by the investigator to be unfit for any reason to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method P-II part: Response Rate P-III part: Overall survival
- Secondary Outcome Measures
Name Time Method P-II part: Adverse events P-III part: Time to treatment failure, response rate, adverse events