Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
NCT ID: NCT00843934
Last Updated: 2012-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
450 participants
INTERVENTIONAL
2009-03-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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anti-cancer agent
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
79 Years
ALL
No
Sponsors
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Nihon University
OTHER
Responsible Party
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Masashi Fujii
Professor
Principal Investigators
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Tadatoshi Takayama, M.D.
Role: PRINCIPAL_INVESTIGATOR
Digestive Surgery Nihon University School of Medicine
Locations
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Department of Digestive Surgery, Nihon University School of Medicine
tabashi City, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Masashi Fujii, MD
Role: primary
Tadatoshi Takayama, MD
Role: backup
Other Identifiers
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ACE500
Identifier Type: -
Identifier Source: org_study_id