Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment radiofrequency ablation
Sponsor First Affiliated Hospital, Sun Yat-Sen University
Collaborator Guangdong Province, Department of Science and Technology
Start date August 2012
End date December 2013
Trial size 20 participants
Trial identifier NCT01668381, 2010B031600209

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Hepatocellular carcinoma patients treated by radiofrequency ablation
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.

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
variation of proliferation suppression ability of CD4+CD25+ T cells of HCC patients before and 1,4 weeks after radiofrequency ablation therapy
time frame: 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
time frame: 4 weeks post therapy

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Enumeration and Function Analysis of Treg Cells in Peripheral Blood of HCC Patients Before and After Ablation Therapy
Principal investigator Qing-qi Ren, Bachelor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University.