Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma.

UMIN ID: UMIN000001153

Registered date:20/05/2008

Basic Information

• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 2007/08/01
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CDDP-LPD group : Powdered cisplatin suspended in lipiodol and mixed with a contrast medium is injected through the catheter selectively introduced into the hepatic artery, followed by embolizing with gelatin particles. The doses of suspension are determined according to tumor size, number of tumors and the location of tumor. If the patients treated with TACE do not have complete uptake of lipiodol, they are retreated with TACE at the interval of 3-4 months.
EPI-LPD group : Epirubicin dissolved in a contrast medium and mixed with lipiodol is injected through the catheter selectively introduced into the hepatic artery, followed by embolizing with gelatin particles. The doses of emulsion are determined according to tumor size, number of tumors and the location of tumor. If the patients treated with TACE do not have complete uptake of lipiodol, they are retreated with TACE at the interval of 3-4 months.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: Overall survival Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Active double cancers. 2. Severe complications (excluding chronic hepatitis and liver cirrhosis). 3. Cardiomyopathy , congestive heart failure or medical history of them. 4. Total dose limiting of anticancer drugs with cardiac toxicity, ex. anthracyclin. 5. Medical history of severe hypersensitivity. 6. Pregnant, lactating women or women with suspected pregnancy. 7. Inappropriate patients for this study judged by the physicians.

Related Information

• Primary Sponsor: Department of Gastroenterology and Hepatology, Okayama University Graguate School of Medicine, Dentistry and Pharmaceutical Sciences.
• Source(s) of Monetary Support: None