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Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

This study is currently recruiting participants.
Verified October 2012 by Nihon University
Sponsor:
Information provided by (Responsible Party):
Masashi Fujii, Nihon University
ClinicalTrials.gov Identifier:
NCT00843934
First received: February 12, 2009
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
 Drug: epirubicin
Drug: Cisplatin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nihon University:

Primary Outcome Measures:
  • response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: March 2009
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Masashi Fujii, Professor, Nihon University
ClinicalTrials.gov Identifier: NCT00843934     History of Changes
Other Study ID Numbers: ACE500
Study First Received: February 12, 2009
Last Updated: October 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 23, 2013