Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Carcinoma, Hepatocellular	Drug: epirubicin; Drug: Cisplatin	Phase 2; Phase 3

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. response rate [ Time Frame: 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Masashi Fujii, Professor, Nihon University
ClinicalTrials.gov Identifier:	NCT00843934 History of Changes
Other Study ID Numbers:	ACE500
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