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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

France1 site
  • CHU Amiens Picardie

    Amiens, Picardie, 80054

Other trials in France

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).

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 groups in NCT03113604
Study groupRoleWhat they receive
Patients with untreated CHC not sorafenibNot described
Receives: Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma
Patients with non-sorafenib CHCNot described
Receives: Other: Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma
Patients with CHCs responding to sorafenibNot 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.

  1. 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.

  1. First posted13 Apr 2017
  2. Study start20 Nov 2015
  3. Primary completion20 Nov 2016
  4. Study completion20 Nov 2016

Why it stopped: The study has been stopped because no one is

Resources

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)
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

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.

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