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NCT02728219 Clinical Trial

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

Recurrent Hepatocellular Carcinoma Clinical Trial

— HCCTACEAFP  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02728219
Other study ID # 2012ZX10002016007002
Secondary ID
Status Completed
Phase N/A
First received March 28, 2016
Last updated March 30, 2016
Start date May 2012
Est. completion date May 2015

Study information
Verified date March 2016
Source Eastern Hepatobiliary Surgery Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date May 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)
• Hepatectomy
Repeat Hepatectomy after postoperation recurrence

Locations
Country Name City State
China Eastern hepatobilliary surgery hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival 3 years Yes
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