Back to resultsComparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion (HCCTACEAFP)
Primary Purpose
Recurrent Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TACE
Hepatectomy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Hepatocellular Carcinoma focused on measuring Recurrent Hepatocellular Carcinoma, transcatheter arterial chemoembolization, AFP conversion
Eligibility Criteria
Inclusion Criteria:
- via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
- age:18-70years
- better liver function (Child-Pugh，class A or B)
Exclusion Criteria:
- reject to attend；
- impossible to come to our hospital for physical examination regularly.
- cancer epitome、seed focus、lymph node or distant metastasis
- Blood clotting function hindrance;
- serious heart、lung、kidney disease
Sites / Locations
- Eastern hepatobilliary surgery hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
hepatectomy
TACE
Arm Description
Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT02728219
First Posted
March 28, 2016
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02728219
Brief Title
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion
Acronym
HCCTACEAFP
Official Title
A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2015 (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
The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion.
Detailed Description
Though many HCC patients have been benefited from hepatectomy treatment, still the high recurrence rate after the hepatectomy led to limited effectiveness.
This is the first study in same case system on comparison of effectiveness among repeat hepatectomy, and TACE with AFP conversion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Hepatocellular Carcinoma
Keywords
Recurrent Hepatocellular Carcinoma, transcatheter arterial chemoembolization, AFP conversion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hepatectomy
Arm Type
Experimental
Arm Description
Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion
Arm Title
TACE
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
transcatheter arterial chemoembolization
Intervention Description
In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE)
Intervention Type
Procedure
Intervention Name(s)
Hepatectomy
Intervention Description
Repeat Hepatectomy after postoperation recurrence
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
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:
via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
age:18-70years
better liver function (Child-Pugh，class A or B)
Exclusion Criteria:
reject to attend；
impossible to come to our hospital for physical examination regularly.
cancer epitome、seed focus、lymph node or distant metastasis
Blood clotting function hindrance;
serious heart、lung、kidney disease
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
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion
We'll reach out to this number within 24 hrs