Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Hepatocellular | Drug: epirubicin Drug: Cisplatin | Phase 2 Phase 3 |
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 |
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
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- response rate [ Time Frame: 6 months ]

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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.
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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.

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
Contact: Masashi Fujii, MD | +81332981711 | masashi.fujii@gioncology.jp | |
Contact: Tadatoshi Takayama, MD | +81339728111 | Takayama.Tadatoshi@nihon-u.ac.jp |
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 |
Principal Investigator: | Tadatoshi Takayama, M.D. | Digestive Surgery Nihon University School of Medicine |
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 |