Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma

Phase 3

Completed

• Conditions: Advanced HCC

• Registration Number: NCT00396682
• Lead Sponsor: Hannover Medical School

Brief Summary

It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-06
• Study First Posted: 2006-11-07
• Study Start: 2007-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• adequate WBC
• adequate liver and kidney function
• no immunodeficiency
• ECOG < 2

Exclusion Criteria

• advanced liver cirrhosis
• severe cardiopulmonary diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of CD4+CD25+regulatory T cells	within 8 weeks
Tumor specific immune responses	within 12 weeks

Secondary Outcome Measures

Name	Time	Method
Toxicity	within 8 weeks
Function and Phenotype of CD4+CD25+ regulatory T cells	within 12 weeks
Tumor response	within 12 weeks
Survival	6 months

Trial Locations

Locations (1)

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany