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临床试验/NCT01668381
NCT01668381Unknown不适用

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 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

次要结局

  • 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)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ming Kuang,MD,PhD

MD,PhD

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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