Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2012 by Masashi Fujii, Nihon University.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00843934

First Posted: February 13, 2009

Last Update Posted: October 19, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Masashi Fujii, Nihon University

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Resource links provided by NLM:

Drug Information available for: Cisplatin Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Further study details as provided by Masashi Fujii, Nihon University:

Primary Outcome Measures:

response rate [ Time Frame: 6 months ]


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

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

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Ages Eligible for Study:	20 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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


Responsible Party:	Masashi Fujii, Professor, Nihon University
ClinicalTrials.gov Identifier:	NCT00843934 History of Changes
Other Study ID Numbers:	ACE500
First Submitted:	February 12, 2009
First Posted:	February 13, 2009
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

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