ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00843934
Recruitment Status : Unknown
Verified October 2012 by Masashi Fujii, Nihon University.
Recruitment status was:  Recruiting
First Posted : February 13, 2009
Last Update Posted : October 19, 2012
Sponsor:
Information provided by (Responsible Party):
Masashi Fujii, Nihon University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: epirubicin Drug: Cisplatin Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Study Start Date : March 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: anti-cancer agent 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.
Other Name: epi-adriamycin

Drug: 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.
Other Name: CDDP


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. response rate [ Time Frame: 6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843934


Contacts
Contact: Masashi Fujii, MD +81332981711 masashi.fujii@gioncology.jp
Contact: Tadatoshi Takayama, MD +81339728111 Takayama.Tadatoshi@nihon-u.ac.jp

Locations
Japan
Department of Digestive Surgery, Nihon University School of Medicine Recruiting
Itabashi, Tokyo, Japan, 173-8610
Contact: Masashi Fujii, MD    +81332931711 ext 207    masashi.fujii@gioncology.jp   
Contact: Tadatoshi Takayama, MD    +81339728111 ext 2471    Takayama.Tadatoshi@nihon-u.ac.jp   
Sponsors and Collaborators
Nihon University
Investigators
Principal Investigator: Tadatoshi Takayama, M.D. Digestive Surgery Nihon University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Masashi Fujii, Professor, Nihon University
ClinicalTrials.gov Identifier: NCT00843934     History of Changes
Other Study ID Numbers: ACE500
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012

Keywords provided by Masashi Fujii, Nihon University:
Carcinoma, Hepatocellular
Trans arterial chemoembolization
Epirubicin
Cisplatin

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Cisplatin
Epirubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action