Hepatocellular CarcinomaMDScanNCT02868255
Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Nantes University Hospital at 1 site in France.
Trial summary
project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer. Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Collection of human samples
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2016to 30 Nov 2018
- Phase
- Observational
- 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
Study population: Several types of samples will be used to test the effect of the drug candidate: 30 inflammatory ascites of HCC patients, 30 HCC resections (both from CHU de Nantes), 30 HCC patient blood samples.
Who may be able to join
- adult
- HCC patients (all BCLC stages accepted)
- patient consent for the use of their biological samples
Who cannot join
- patient with other cancers
- hepatitis C or B positive
- HCC treatment by chemo-embolization under 3 months
- under Sorafenib treatment within the month prior to collection
- underage or under guardianship patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myeloid Derived Suppressor Cells Control by SIRP-alpha: Investigation in Hepatocellular Carcinoma
project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.
Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Collection of human samples
- Keywords
- Biobank analyses, Effect evaluation of the drug, patient-derived cells, SIRPα/CD47 expression
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of human samplesProcedure or surgery
Several types of samples will be used to test the effect of the drug candidate
| Study group | Role | What they receive |
|---|---|---|
| Ascites | 30 inflammatory ascites of HCC patients (Collection of human samples ) Ascites will be selected only from HCC patients with an elevated protein level (ie inflammatory ascites) Puncture of ascites will be collected by paracentesis on HCC or ovarian cancer patients during their routine care These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). Receives: Procedure: Collection of human samples | |
| Resections | 30 HCC resections (Collection of human samples ) Fragment of resected HCC will be obtained after surgery and histological analysis will be performed by the anatomo-pathology service These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). Receives: Procedure: Collection of human samples | |
| blood samples | blood samples (Collection of human samples )will be collected prospectively for complementary functional analysis of peripheral These biological samples are affiliated with the biocollection "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). Receives: Procedure: Collection of human samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the SIRP/CD47 expression
samples harvested from HCC and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-hSIRP Ab on various cellular types from patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start3 Jan 2016
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle ARCHAMBEAUD, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868255
- Sponsor's protocol ID
- RC16_0156
- Acronym
- MDScan
- Status last verified
- Sep 2021
- First submitted
- 16 Jun 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid Derived Suppressor Cells Control by SIRP-alpha: Investigation in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02868255
- Acronym / sponsor ID
- MDScan / RC16_0156
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Biobank analyses, Effect evaluation of the drug, patient-derived cells, SIRPα/CD47 expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 16 Aug 2016 (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.
project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.
Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ascites | – | Procedure: Collection of human samples30 inflammatory ascites of HCC patients (Collection of human samples ) Ascites will be selected only from HCC patients with an elevated protein level (ie inflammatory ascites) Puncture of ascites will be collected by paracentesis on HCC or ovarian cancer patients during their routine care These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). |
| Resections | – | Procedure: Collection of human samples30 HCC resections (Collection of human samples ) Fragment of resected HCC will be obtained after surgery and histological analysis will be performed by the anatomo-pathology service These biological samples are affiliated with the biobank "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). |
| blood samples | – | Procedure: Collection of human samplesblood samples (Collection of human samples )will be collected prospectively for complementary functional analysis of peripheral These biological samples are affiliated with the biocollection "hépato-gastroentérologie du CHU de Nantes" (declared under the reference DC-2011-1399). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Several types of samples will be used to test the effect of the drug candidate: 30 inflammatory ascites of HCC patients, 30 HCC resections (both from CHU de Nantes), 30 HCC patient blood samples.
Key inclusion criteria (3 listed)
- adult
- HCC patients (all BCLC stages accepted)
- patient consent for the use of their biological samples
Key exclusion criteria (5 listed)
- patient with other cancers
- hepatitis C or B positive
- HCC treatment by chemo-embolization under 3 months
- under Sorafenib treatment within the month prior to collection
- underage or under guardianship patients
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 |
|---|---|---|
| Collection of human samplesSeveral types of samples will be used to test the effect of the drug candidate | Procedure or surgery | Ascites, Resections, blood samples |
Primary outcome
evaluation of the SIRP/CD47 expression
Time frame: baseline
samples harvested from HCC and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-hSIRP Ab on various cellular types from patients
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Isabelle ARCHAMBEAUD, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 5 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 24 Jun 2026. 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 France. 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.
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?
evaluation of the SIRP/CD47 expression (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.