Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion

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. Identifier: NCT00826384
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Brief Summary:
According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: balloon catheter Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1,Single-blind, Randomized, Controlled Study to Evaluate the Safety and Effectivity of TACE Therapy of HCC(Hepatocellular Carcinoma) With Blocking Tumor Blood Temporarily and Enhancing Perfu
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Intervention Details:
    Procedure: balloon catheter
    transcatheter arterial chemoembolization therapy with balloon catheter

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • sign the written informed consent form provided.
  • diagnosed clinically as HCC,need to take TACE.

Exclusion Criteria:

  • have had an allergic reaction following iodine.
  • have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
  • HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.

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 identifier (NCT number): NCT00826384

China, Shanghai
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Study Chair: Feng Shen, MD Eastern hepatobilliary surgery hospital

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital Identifier: NCT00826384     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-001
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
hepatocellular carcinoma
transcatheter arterial chemoembolization
overall survival

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases