Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion (HCCTACEAFP)

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Prospective Randomized Trial Comparing Treatment of Recurrent HCC With Repeat Hepatectomy,and Transcatheter Arterial Chemoembolization (TACE) With AFP Conversion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. via clinical diagnosis and confirm it is early recurrent liver cancer with AFP conversion, and not accept any anticancer treatment.
  2. age:18-70years
  3. better liver function (Child-Pugh，class A or B)

Exclusion Criteria:

  1. reject to attend；
  2. impossible to come to our hospital for physical examination regularly.
  3. cancer epitome、seed focus、lymph node or distant metastasis
  4. Blood clotting function hindrance;
  5. serious heart、lung、kidney disease

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
Active Comparator: TACE
Procedure: Hepatectomy
Repeat Hepatectomy after postoperation recurrence
Experimental: hepatectomy
Comparison of Treatment of recurrent hepatocellular carcinoma with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP conversion
Procedure: TACE
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)
Other Names:
  • transcatheter arterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Eastern Hepatobiliary Surgery Hospital

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

May 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012ZX10002016007002

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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