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)

UMIN ID: UMIN000000975

Registered date:08/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma
• Date of first enrollment: 2008/01/01
• Target sample size: 100
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Interventional
• Intervention(s): Patients with unresectable HCC undergo TACE using an emulsion of epirubicin HCl or doxorubicin HCl and Lipiodol, followed by injection of gelatin sponge particles. The same treatment is repeated if the tumor demonstrates progression.

Outcome(s)

• Primary Outcome: 2-year survival rate
• Secondary Outcome: incidence and grade of adverse events, response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Secondary Sponsor: Korea Interventional Radiology in Oncology Study Group (KIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare