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

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: radiofrequency ablation

• Registration Number: NCT01668381
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study First Submitted: 2012-03-18
• Study Start: 2012-08
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-20
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients	radiofrequency ablation	Hepatocellular carcinoma patients treated by radiofrequency ablation

Primary Outcome Measures

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

Name	Time	Method
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	CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.CD4+CD25- and CD8+ T cells proliferation changes were analysed to test CD4+CD25+ T cell suppression ability.
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	CD4+CD25+ T cells, derived from peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation therapy,were co-cultured with CD4+CD25- or CD8+ T cells,which were stimulated by CD3/CD28 MACSiBead Particles.supernatant IFN-γ were analysed to test CD4+CD25+ T cell suppression ability.

Trial Locations

Locations (1)

Sun Yat-Sen University,First Affiliated Hospital; 🇨🇳 Guangzhou, Guangdong, China