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

February 12, 2009
October 17, 2012
March 2009
December 2012   (final data collection date for primary outcome measure)
response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00843934 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
  • 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
Experimental: anti-cancer agent
Interventions:
  • Drug: epirubicin
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
February 2015
December 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 79 Years
No
Contact: Masashi Fujii, MD +81332981711 masashi.fujii@gioncology.jp
Contact: Tadatoshi Takayama, MD +81339728111 Takayama.Tadatoshi@nihon-u.ac.jp
Japan
 
NCT00843934
ACE500
Yes
Masashi Fujii, Nihon University
Nihon University
Not Provided
Principal Investigator: Tadatoshi Takayama, M.D. Digestive Surgery Nihon University School of Medicine
Nihon University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP