NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001153

Registered date:20/05/2008

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHepatocellular carcinoma
Date of first enrollment2007/08/01
Target sample size360
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeResponse Rate
Secondary OutcomeOverall survival Safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Contact

public contact
Name Yoshiyuki Kobayashi
Address 2-5-1, Shikata-cho, Okayama-shi, Okayama 700-8558, Japan Japan
Telephone 086-235-7219
E-mail ykobaya@md.okayama-u.ac.jp
Affiliation Okayama University Hospital Department of Gastroenterology and Hepatology
scientific contact
Name Kazuhide Yamamoto
Address 2-5-1, Shikata-cho, Okayama-shi, Okayama 700-8558, Japan Japan
Telephone 086-235-7219
E-mail
Affiliation Okayama University Graguate School of Medicine, Dentistry and Pharmaceutical Sciences. Department of Gastroenterology and Hepatology