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Clinical Trials/NCT01668381
NCT01668381
Unknown
Not Applicable

Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy

First Affiliated Hospital, Sun Yat-Sen University1 site in 1 country20 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatocellular Carcinoma
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Enrollment
20
Locations
1
Primary Endpoint
variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to determine the enumeration and function changes of regulatory t cells in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation therapy.

Detailed Description

Regulatory T cells,which are also called Treg cells,play an important role in suppressing anti-tumor immunity.Accumulated evidences indicate that Treg cells are elevated in peripheral blood,however,there are also reports that decreased Treg cells are found in hepatocellular patients.This study focuses on the changes of Treg cells ratio in peripheral blood of hepatocellular carcinoma patients before and 1 week, 4 weeks after ablation ,also its functional cytokines,such as TGF-β,IL-10,IFN-γ,and inhibition function when co-cultured with CD4+CD25-、CD8+ cells. The investigators speculate that a decreased Treg ratio will be found in patients who receive ablation therapy,and its function cytokines,moreover,CD4+CD25-、CD8+ cells' proliferation and function could be inhibited when co-cultured with Treg cells.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2013
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible Party
Principal Investigator
Principal Investigator

Ming Kuang,MD,PhD

MD,PhD

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

  • hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of hepatocellular carcinoma and alphafetoprotein\>400μg/L;or two or more dynamic imagine with a diagnosis of hepatocellular carcinoma
  • Child-Pugh A or B
  • well preserved renal and hematopoietic Function
  • receive ablation therapy through percutaneous radiofrequency ablation or microwave ablation or ethanol injection ablation or any kind of combination of them.
  • achieve complete ablation accessed by contrast-enhanced CT

Exclusion Criteria

  • incomplete ablation
  • remote metastasis
  • Child-Pugh C
  • general infection
  • autoimmune diseases
  • suffer from other tumors concurrently or in last five years
  • patients with immune deficit or infected by HIV
  • receiving glucocorticoid or other medicine inhibiting immune system

Outcomes

Primary Outcomes

variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

Time Frame: 4 weeks post therapy

changes of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,such as CD3+,CD4+,CD8+,CD4+CD25+FOXP3+(Treg) cells.

variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

Time Frame: 4 weeks post therapy

variation of serum IL-10,TGF-β1,IFN-γ concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

Secondary Outcomes

  • variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy(4 weeks post therapy)
  • variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation therapy(4 weeks post therapy)

Study Sites (1)

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