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OpenTrials
Completed

NCT Number: NCT00396682

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

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.

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Key information

Conditions

Advanced HCC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Hochschule Hannover

Hanover, 30655, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • advanced liver cirrhosis
  • severe cardiopulmonary diseases

Treatment and study plan

Cyclophosphamide

Drug

150 - 250 - 350 mg

Primary outcomes

  1. Frequency of CD4+CD25+regulatory T cells

    Time frame: within 8 weeks

  2. Tumor specific immune responses

    Time frame: within 12 weeks

Secondary outcomes

  1. Toxicity

    Time frame: within 8 weeks

  2. Function and Phenotype of CD4+CD25+ regulatory T cells

    Time frame: within 12 weeks

  3. Tumor response

    Time frame: within 12 weeks

  4. Survival

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 7, 2006
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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