Advanced HCCPhase 3NCT00396682
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma
A Phase 3 study testing Cyclophosphamide in people with Advanced HCC, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HCC
- What is being tested?
- Cyclophosphamide
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adequate WBC
- adequate liver and kidney function
- no immunodeficiency
- ECOG < 2
Who cannot join
- advanced liver cirrhosis
- severe cardiopulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide
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.
- Conditions
- Advanced HCC
- Being tested
- Cyclophosphamide
- Keywords
- HCC, T cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
150 - 250 - 350 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of CD4+CD25+regulatory T cells
Measured: within 8 weeks
Tumor specific immune responses
Measured: within 12 weeks
Secondary outcomes (4)
Toxicity
Measured: within 8 weeks
Function and Phenotype of CD4+CD25+ regulatory T cells
Measured: within 12 weeks
Tumor response
Measured: within 12 weeks
Survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Tim F Greten, M.D., Principal investigator, Department of Gastroenterology, Medizinische Hochschule HannoverTim F Greten, M.D., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396682
- Sponsor's protocol ID
- HAN-HCC-002
- Other IDs
- DFG - KFO 119
- Status last verified
- Feb 2009
- First submitted
- 6 Nov 2006
- Last updated
- 4 Feb 2009
- Results posted
- No
Publications
Greten TF, Ormandy LA, Fikuart A, Hochst B, Henschen S, Horning M, Manns MP, Korangy F. Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC. J Immunother. 2010 Feb-Mar;33(2):211-8. doi: 10.1097/CJI.0b013e3181bb499f.
PubMed 20139774
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of CD4+CD25+ Regulatory T Cells in Patients With Advanced HCC After Treatment With Cyclophosphamide
- ClinicalTrials.gov ID
- NCT00396682
- Acronym / sponsor ID
- HAN-HCC-002
- Conditions
- Advanced HCC
- Keywords
- HCC, T cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adequate WBC
- adequate liver and kidney function
- no immunodeficiency
- ECOG < 2
Key exclusion criteria (2 listed)
- advanced liver cirrhosis
- severe cardiopulmonary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide150 - 250 - 350 mg | Drug | – |
Primary outcome
Frequency of CD4+CD25+regulatory T cells
Time frame: within 8 weeks
Tumor specific immune responses
Time frame: within 12 weeks
4 secondary outcomes
Toxicity
Time frame: within 8 weeks
Function and Phenotype of CD4+CD25+ regulatory T cells
Time frame: within 12 weeks
Tumor response
Time frame: within 12 weeks
Survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Derived from this study: PubMed 20139774Greten TF, Ormandy LA, Fikuart A, Hochst B, Henschen S, Horning M, Manns MP, Korangy F. Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC. J Immunother. 2010 Feb-Mar;33(2):211-8. doi: 10.1097/CJI.0b013e3181bb499f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim F Greten, M.D. principal investigator
Department of Gastroenterology, Medizinische Hochschule Hannover
Tim F Greten, M.D. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclophosphamide in people with Advanced HCC, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of CD4+CD25+regulatory T cells (time frame: within 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.