Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).

Official Title
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Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: epirubicin
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions. Subject must to be the first experience of TACE. Subject has no extra-hepatic tumor and no obstruction of main portal vein. Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy). ECOG performance status 0-2 Child-pugh Class A or B Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below: Serum Total Bilirubin 2.0mg/mL WBC 3000/mm3 PLT 50000/mm3 Hb 9.0g/dL Creatinine ; upper normal limit (UNL) BUN 25mg/dL Written informed consent Exclusion Criteria: Subject has extra hepatic metastasis. Tumor thrombosis exists at main portal vein. Remarkable artery-portal vein shunt or veno-arterial shunt. Uncontrollable ascites or pleural effusion. History of severe hypersensitivity. Any previous TACE or TAE for HCC. Any previous chemotherapy using epirubicin or CDDP. Complications as below (except chronic hepatitis or liver cirrhosis) Severe heart disease Myocardial infarction within 6 months Renal insufficiency Active infections (except virous hepatitis) Gastrointestinal bleeding Active double cancer Hepatic encephalopathy or heavy mental disorder. Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. Any subject judged by the investigator to be unfit for any reason to participate in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-cancer agent<br> | Drug: epirubicin<br>* Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. 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.<br>* Other names: epi-adriamycin;Drug: Cisplatin<br>* Arm C: 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.<br>* Other names: CDDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epirubicin, Carcinoma, Hepatocellular, Trans arterial chemoembolization, Cisplatin