Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

Nihon University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Cisplatin; Drug: epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00843934

ACE500

Details and patient eligibility

About

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).

Enrollment: 450 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 1 patient group

anti-cancer agent

Experimental group

Treatment:

Drug: epirubicin

Drug: Cisplatin