Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nihon University
• Treatments: Cisplatin; Epirubicin

Criteria

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.