JPRN-UMIN000000975
Completed
Phase 2
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) - Expanded Treatment Efficacy and Safety Study of TACE for Unresectable HCC: Korea-Japan Cooperative Study (JIVROSG-0604)
Japan Interventional Radiology in Oncology Study Group (JIVROSG)0 sites100 target enrollmentJanuary 8, 2008
Conditionshepatocellular carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- hepatocellular carcinoma
- Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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