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Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Phase 2/Phase 3
20 Years
79 Years
Open (Enrolling)
Carcinoma, Hepatocellular

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Trial Information

Randomized Controlled 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Tadatoshi Takayama, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Digestive Surgery Nihon University School of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

March 2009

Completion Date:

February 2015

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma, Hepatocellular
  • Trans arterial chemoembolization
  • Epirubicin
  • Cisplatin
  • Carcinoma
  • Carcinoma, Hepatocellular