Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

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.