JPRN-UMIN000001384
Completed
Phase 2
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma - ACE 500 Study
ACE 500 Study Group0 sites450 target enrollmentOctober 14, 2008
ConditionsHepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- ACE 500 Study Group
- Enrollment
- 450
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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