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

Hannover Medical School (MHH)

Status and phase: Completed; Phase 3

Conditions: Advanced HCC

Treatments: Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00396682

DFG - KFO 119

HAN-HCC-002

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• advanced liver cirrhosis
• severe cardiopulmonary diseases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)