Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (ACE500)

October 17, 2012 updated by: Masashi Fujii, Nihon University

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Itabashi, Tokyo, Japan, 173-8610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CDDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon University

Investigators

  • Principal Investigator: Tadatoshi Takayama, M.D., Digestive Surgery Nihon University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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