Hepatocyte ReceptorSLAMF3NCT03113604
Analysis of the Role of Hepatocyte SLAMF3 Receptor and Drug Resistance Proteins (MDR) in Resistance to Treatment With Sorafenib in CHC Patients
An observational study of Hepatocyte Receptor and Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in humans; 9th in women (figures from the Association for Research against Cancer ARC). This cancer is a major public health problem on a global scale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocyte Receptor, Hepatocellular Carcinoma
- What is being tested?
- Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2015to 20 Nov 2016
- 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
- Adult, Older adult
Study population: Group 1: Tumor and peri-tumor tissue samples from patients with non-treated sorafenib CHC (surgical resection or other) Group 2: Tumor and peri-tumor tissue samples from tumor and peritumor tissues of patients not responding to sorafenib treatment Group 3: samples from patients responding to treatment with sorafenib
Who may be able to join
- Patients over 18 years of age,
- Diagnosis of hepatocellular carcinoma (histological or non-invasive criteria of Barcelona),
- Group 1: Tumor and peri-tumor tissue samples from patients with untreated CHCs sorafenib
- Patients who received treatment other than sorafenib (chemo-embolization, radiofrequency, resection, ...),
- Group 2: Tumor and peri-tumor tissue samples from patients with non-sorafenib CHC
- Patients treated with sorafenib,
Show all 10Show fewer
- Patients not responding to treatment with sorafenib
- Group 3: Tumor and peri-tumor tissue samples from patients with CHCs responding to sorafenib
- Patients treated with sorafenib,
- Patients responding to treatment with sorafenib
Who cannot join
- Age <18 years,
- Patients who do not have liver biopsy specimens (PBH) available at the tumor bank,
- Patients who have refused to use their samples for biomedical research,
- Pregnancy and breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in humans; 9th in women (figures from the Association for Research against Cancer ARC). This cancer is a major public health problem on a global scale. Patients, whose diagnosis is often late, are at advanced stages of the pathology, even those who benefit from locoregional treatments have a poor prognosis and suffer from a lack of curative therapeutic strategies. CHC is highly refractory to cytotoxic chemotherapy and so far the response rates to conventional systemic chemotherapy has provided a clinical benefit where survival was prolonged by more than 25% in patients with advanced CHC. Further efforts are needed to effectively manage HCC. Knowledge of the mechanisms regulating proliferation and inhibiting the sensitivity of transformed cells to apoptosis is the key to the development of more effective therapeutic strategies.
Several new therapies, called targeted therapies, are tested in clinical trials. Currently, the most effective molecular agent for targeting the Raf pathway is sorafenib capable of also inhibiting tyrosine kinases of VEGFR and PDGFR. Sorafenib, a multikinase inhibitor, decreases the proliferation of tumor cells in vitro that inhibit the activity of targets present in tumor cells (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and tumor vascularization VEGFR-2, VEGFR-3, and PDGFR-beta). Despite the real benefit of this treatment, its efficacy (three months of overall survival) and its indication remain limited to Child-Pugh A, WHO 0-2 patients in whom curative treatment is contraindicated. In addition, several patients have resistance to Sorafenib and thus find themselves in therapeutic failure, thus limiting the therapeutic choice for these patients.
Resistance to treatment with Sorafenib limits the therapeutic choice. The mechanisms responsible for this resistance remain to be elucidated. Drug resistance proteins, MDR Multi-Drug Resistance, is a family of molecules whose expression increases in the cancer cell and ensures the repression of chemotherapy molecules outside the target cancer cell. This family includes the proteins ABCG2, MDR and MRP1. Our in vitro studies show that treatment of CHC Huh-7 cells with Sorafenib (10 mM) induces the specific expression of the transcripts of the MRP-1 protein without any effect on the expression of the ABCG2 and MDR protein. In addition, sorafenib has an effect on the expression of hepatocyte SLAMF3 receptor transcripts, a receptor recently identified in hepatocyte tissue. Indeed, it has been shown that the expression of SLAMF3 is lowered in the cancerous tissue compared to the healthy tissue and that the reintroduction of a strong expression in the cancer cell inhibits its proliferation by inhibiting the MAPK Erk pathway, Cancer cells to apoptosis and inhibits the uptake of tumor masses in the Nude mouse (I. Marcq, et al., 2013).
- Conditions
- Hepatocyte Receptor, Hepatocellular Carcinoma
- Being tested
- Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinomaOther
Retrospective study of samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma (HCC): three groups of samples will be selected:
Group 1: Tumor and peri-tumor tissue samples from patients with non-treated sorafenib CHC (surgical resection or other) Group 2: Tumor and peri-tumor tissue samples from tumor and peritumor tissues of patients not responding to sorafenib treatment Group 3: samples from patients responding to treatment with sorafenib
| Study group | Role | What they receive |
|---|---|---|
| Patients with untreated CHC not sorafenib | Not described Receives: Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma | |
| Patients with non-sorafenib CHC | Not described Receives: Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma | |
| Patients with CHCs responding to sorafenib | Not described Receives: Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of expression of SLAM3 and MDR transcripts, correlation with the responder status or not with Sorafenib
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start20 Nov 2015
- Primary completion20 Nov 2016
- Study completion20 Nov 2016
Why it stopped: The study has been stopped because no one is
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocyte ReceptorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113604
- Sponsor's protocol ID
- PI2015_843_0021
- Acronym
- SLAMF3
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Role of Hepatocyte SLAMF3 Receptor and Drug Resistance Proteins (MDR) in Resistance to Treatment With Sorafenib in CHC Patients
- ClinicalTrials.gov ID
- NCT03113604
- Acronym / sponsor ID
- SLAMF3 / PI2015_843_0021
- Conditions
- Hepatocyte Receptor, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has been stopped because no one is
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 20 Nov 2016 (actual)
- Study completion
- 20 Nov 2016 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in humans; 9th in women (figures from the Association for Research against Cancer ARC). This cancer is a major public health problem on a global scale. Patients, whose diagnosis is often late, are at advanced stages of the pathology, even those who benefit from locoregional treatments have a poor prognosis and suffer from a lack of curative therapeutic strategies. CHC is highly refractory to cytotoxic chemotherapy and so far the response rates to conventional systemic chemotherapy has provided a clinical benefit where survival was prolonged by more than 25% in patients with advanced CHC. Further efforts are needed to effectively manage HCC. Knowledge of the mechanisms regulating proliferation and inhibiting the sensitivity of transformed cells to apoptosis is the key to the development of more effective therapeutic strategies.
Several new therapies, called targeted therapies, are tested in clinical trials. Currently, the most effective molecular agent for targeting the Raf pathway is sorafenib capable of also inhibiting tyrosine kinases of VEGFR and PDGFR. Sorafenib, a multikinase inhibitor, decreases the proliferation of tumor cells in vitro that inhibit the activity of targets present in tumor cells (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and tumor vascularization VEGFR-2, VEGFR-3, and PDGFR-beta). Despite the real benefit of this treatment, its efficacy (three months of overall survival) and its indication remain limited to Child-Pugh A, WHO 0-2 patients in whom curative treatment is contraindicated. In addition, several patients have resistance to Sorafenib and thus find themselves in therapeutic failure, thus limiting the therapeutic choice for these patients.
Resistance to treatment with Sorafenib limits the therapeutic choice. The mechanisms responsible for this resistance remain to be elucidated. Drug resistance proteins, MDR Multi-Drug Resistance, is a family of molecules whose expression increases in the cancer cell and ensures the repression of chemotherapy molecules outside the target cancer cell. This family includes the proteins ABCG2, MDR and MRP1. Our in vitro studies show that treatment of CHC Huh-7 cells with Sorafenib (10 mM) induces the specific expression of the transcripts of the MRP-1 protein without any effect on the expression of the ABCG2 and MDR protein. In addition, sorafenib has an effect on the expression of hepatocyte SLAMF3 receptor transcripts, a receptor recently identified in hepatocyte tissue. Indeed, it has been shown that the expression of SLAMF3 is lowered in the cancerous tissue compared to the healthy tissue and that the reintroduction of a strong expression in the cancer cell inhibits its proliferation by inhibiting the MAPK Erk pathway, Cancer cells to apoptosis and inhibits the uptake of tumor masses in the Nude mouse (I. Marcq, et al., 2013).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with untreated CHC not sorafenib | – | Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma |
| Patients with non-sorafenib CHC | – | Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma |
| Patients with CHCs responding to sorafenib | – | Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Group 1: Tumor and peri-tumor tissue samples from patients with non-treated sorafenib CHC (surgical resection or other) Group 2: Tumor and peri-tumor tissue samples from tumor and peritumor tissues of patients not responding to sorafenib treatment Group 3: samples from patients responding to treatment with sorafenib
Key inclusion criteria (10 listed)
- Patients over 18 years of age,
- Diagnosis of hepatocellular carcinoma (histological or non-invasive criteria of Barcelona),
- Group 1: Tumor and peri-tumor tissue samples from patients with untreated CHCs sorafenib
- Patients who received treatment other than sorafenib (chemo-embolization, radiofrequency, resection, ...),
- Group 2: Tumor and peri-tumor tissue samples from patients with non-sorafenib CHC
Key exclusion criteria (4 listed)
- Age <18 years,
- Patients who do not have liver biopsy specimens (PBH) available at the tumor bank,
- Patients who have refused to use their samples for biomedical research,
- Pregnancy and breast feeding
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 |
|---|---|---|
| Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinomaRetrospective study of samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma (HCC): three groups of samples will be selected: Group 1: Tumor and peri-tumor tissue samples from patients with non-treated sorafenib CHC (surgical resection or other) Group 2: Tumor and peri-tumor tissue samples from tumor and peritumor tissues of patients not responding to sorafenib treatment Group 3: samples from patients responding to treatment with sorafenib | Other | Patients with CHCs responding to sorafenib, Patients with non-sorafenib CHC, Patients with untreated CHC not sorafenib |
Primary outcome
Rate of expression of SLAM3 and MDR transcripts, correlation with the responder status or not with Sorafenib
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatocyte Receptor and Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire, Amiens 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 10 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of expression of SLAM3 and MDR transcripts, correlation with the responder status or not with Sorafenib (time frame: 1 day). 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 13 Apr 2017.