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

NCT ID: NCT01668381

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC patients

Hepatocellular carcinoma patients treated by radiofrequency ablation

radiofrequency ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Province, Department of Science and Technology

OTHER_GOV

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang,MD,PhD

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, MD,PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Qing-qi Ren, Bachelor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

Sun Yat-Sen University,First Affiliated Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2010B031600209

Identifier Type: -

Identifier Source: org_study_id