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

Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396682

Enrollment

Registered

2006-11-07

Start date

2007-02-28

Completion date

2008-12-31

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced HCC

Keywords

HCC, T cell

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.

Interventions

DRUGCyclophosphamide

150 - 250 - 350 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adequate WBC * adequate liver and kidney function * no immunodeficiency * ECOG \< 2

Exclusion criteria

* advanced liver cirrhosis * severe cardiopulmonary diseases

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026