Back to resultsTransarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
balloon catheter
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, transcatheter arterial chemoembolization, overall survival
Eligibility 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.
Sites / Locations
- Eastern hepatobilliary surgery hospital
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00826384
First Posted
January 21, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00826384
Brief Title
Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, transcatheter arterial chemoembolization, overall survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
balloon catheter
Intervention Description
transcatheter arterial chemoembolization therapy with balloon catheter
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Shen, MD
Organizational Affiliation
Eastern hepatobilliary surgery hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Learn more about this trial
Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion
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