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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00826384
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
 Procedure: balloon catheter
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: balloon catheter
    transcatheter arterial chemoembolization therapy with balloon catheter
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826384

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

No publications provided

Responsible Party: ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00826384     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-001
Study First Received: January 21, 2009
Last Updated: January 21, 2009
Health Authority: China: Ministry of Health
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 16, 2013