Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

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:

  1. Serum Total Bilirubin 2.0mg/mL
  2. WBC 3000/mm3
  3. PLT 50000/mm3
  4. Hb 9.0g/dL
  5. Creatinine ; upper normal limit (UNL)
  6. 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)

  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.
* 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.