Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

— ACE500  

Official title:

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00843934
• Other study ID #: ACE500
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 12, 2009
• Last updated: October 17, 2012
• Start date: March 2009
• Est. completion date: February 2015

Study information

• Verified date: October 2012
• Source: Nihon University
• Contact: Masashi Fujii, MD
• Phone: +81332981711
• Email: masashi.fujii[@]gioncology.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: February 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• epirubicin
Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.
• Cisplatin
Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Locations

Country	Name	City	State
Japan	Department of Digestive Surgery, Nihon University School of Medicine	Itabashi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		6 months	No