Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

UMIN ID: UMIN000001384

Registered date:14/10/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 2008/09/01
• Target sample size: 450
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pomping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.
Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Outcome(s)

• Primary Outcome: P-II part: Response Rate P-III part: Overall survival
• Secondary Outcome: P-II part: Adverse events P-III part: Time to treatment failure, response rate, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Subject has extra hepatic metastasis. 2. Tumor thrombosis exists at main portal vein. 3. Remarkable artery-portal vein shunt or veno-arterial shunt. 4. Uncontrollable ascites or pleural effusion. 5. History of severe hypersensitivity. 6. Any previous TACE or TAE for HCC. 7. Any previous chemotherapy using epirubicin or CDDP. 8. Complications as below (except chronic hepatitis or liver cirrhosis) 1) Severe heart disease 2) Myocardial infarction within 6 months 3) Renal insufficiency 4) Active infections (except virous hepatitis) 5) Gastrointestinal bleeding 6) Active double cancer 7) Hepatic encephalopathy or heavy mental disorder. 9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. 10. Any subject judged by the investigator to be unfit for any reason to participate in the study.

Related Information

• Primary Sponsor: ACE 500 Study Group
• Source(s) of Monetary Support: Nihon University School of Medicine