Randomized controlled study of TACE therapy for HCC comparing epi-ADM and CDDP

UMIN ID: C000000372

Registered date:31/05/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 2005/10/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Make Cisplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion.
Dissolve Epirubicin in a contrast medium and then mix with Lipiodol, and infuse it into hepatic artery, followed by Gelpart infusion.

Outcome(s)

• Primary Outcome: Anti-tumor activity (Response rate = CR+PR). Response will be evaluated mainly according to the EASL (European Association for the Study of the Liver) guideline. . Secondarily it will be evaluated according to the Criteria for the Evaluation of Direct Effects of Hepatocellular Carcinoma (2004) and RESIST.
• Secondary Outcome: Survival rate and local-relapse-free survival/QOL survey

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)A patient who has severe complications (however chronic hepatitis and liver cirrhosis are excluded for this criteria). 2)A patient who has active double cancers (besides HCC, the double cancers which can decide the prognosis). 3)A patient who has a medical history of severe hyperesthesia. 4)A patient who is pregnant, a nursing mother or is suspected of being pregnant. 5)A patient who is decided by the principal investigator or a clinical investigator not to be an adequate subject for this study.

Related Information

• Primary Sponsor: Department of Internal Medicine Keio University School of Medicine
• Source(s) of Monetary Support: None