Back to resultsTrial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
Primary Purpose
Carcinoma, Hepatocellular
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
epirubicin
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Carcinoma, Hepatocellular, Trans arterial chemoembolization, Epirubicin, Cisplatin
Eligibility 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:
- Serum Total Bilirubin 2.0mg/mL
- WBC 3000/mm3
- PLT 50000/mm3
- Hb 9.0g/dL
- Creatinine ; upper normal limit (UNL)
- 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)
- Severe heart disease
- Myocardial infarction within 6 months
- Renal insufficiency
- Active infections (except virous hepatitis)
- Gastrointestinal bleeding
- Active double cancer
- 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.
Sites / Locations
- Department of Digestive Surgery, Nihon University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-cancer agent
Arm Description
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00843934
Brief Title
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Acronym
ACE500
Official Title
Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nihon University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Carcinoma, Hepatocellular, Trans arterial chemoembolization, Epirubicin, Cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-cancer agent
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
epirubicin
Other Intervention Name(s)
epi-adriamycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
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.
Primary Outcome Measure Information:
Title
response rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Serum Total Bilirubin 2.0mg/mL
WBC 3000/mm3
PLT 50000/mm3
Hb 9.0g/dL
Creatinine ; upper normal limit (UNL)
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)
Severe heart disease
Myocardial infarction within 6 months
Renal insufficiency
Active infections (except virous hepatitis)
Gastrointestinal bleeding
Active double cancer
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masashi Fujii, MD
Phone
+81332981711
Email
masashi.fujii@gioncology.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Tadatoshi Takayama, MD
Phone
+81339728111
Email
Takayama.Tadatoshi@nihon-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadatoshi Takayama, M.D.
Organizational Affiliation
Digestive Surgery Nihon University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Digestive Surgery, Nihon University School of Medicine
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masashi Fujii, MD
Phone
+81332931711
Ext
207
Email
masashi.fujii@gioncology.jp
First Name & Middle Initial & Last Name & Degree
Tadatoshi Takayama, MD
Phone
+81339728111
Ext
2471
Email
Takayama.Tadatoshi@nihon-u.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
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