Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
- 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
- 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