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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01668381
• Other study ID #: 2010B031600209
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2012
• Last updated: February 20, 2013
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• radiofrequency ablation
the patients are prepared by local anesthesia and intravenous sedative.guided by the ultrasound,the antenna used for radiofrequency ablation ablation is placed in the tumor to destroy tumor tissues,the output power and duration are depended by the tumor volume and location.

Locations

Country	Name	City	State
China	Sun Yat-Sen University,First Affiliated Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Guangdong Province, Department of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of absolute counting of T cell subsets in peripheral blood of HCC patients before and 1,4 weeks after radiofrequency ablation 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.	4 weeks post therapy	No
Primary	variation of serum IL-10,TGF-ß1,IFN-? concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy	variation of serum IL-10,TGF-ß1,IFN-? concentration of HCC patients before and 1,4 weeks after radiofrequency ablation therapy	4 weeks post therapy	No
Secondary	variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation 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.	4 weeks post therapy	No
Secondary	variation of suppression ability of CD4+CD25+ T cells of HCC patients on cytokine secretion before and 1,4 weeks after radiofrequency ablation 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-? were analysed to test CD4+CD25+ T cell suppression ability.	4 weeks post therapy	No