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TerminatedNo phase

Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
People taking part
4 people enrolled
Started
8 Sept 2023
Ended
22 Sept 2025
Type of study
Observational
Treatments tested
  • patients with hepatocellular carcinoma
Record updated
18 December 2025
Why it stopped
Abandon of study

Who can take part

Age
18 years to 90 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Advanced hepatocellular carcinoma with an indication of systemic therapy by Atezolizumab-Bevacizumab
  • At least one measurable untreated lesion
  • ECOS performance status of 0 or 1

Who cannot take part

  • HIV/ immunosuppressive treatment
  • Active of history of autoimmune disease or immune deficiency
  • Priori history of liver transplantation or systemic porto shunt
  • Pregnant of breastfeeding women

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Hepatocellular carcinoma (HCC) is the third leading cause of cancer death worldwide. Treatment options for advanced HCC remain very limited. Until recently, multikinase inhibitor were the gold standard for advanced hepatocellular carcinoma but associated with poor outcome and important side effects. Recently, the positive results of the Imbrave 150 study (a randomized study comparing Atezolizumab + Bevacizumab versus Sorafenib) prompted us to redefine our management strategy for advanced hepatocellular carcinoma by proposing the combination of Atezolizumab/Bevacizumab as treatment first-line in patients with advanced hepatocellular carcinoma. However, only 1/3 of the patients will respond to the combination of treatment and identifying predictive factors of response and new immune checkpoint inhibitors in order to target more tumors appear as a major issue. In this context, recent work has underlined the importance of the activating CD226/DNAM-1 receptor as an original immunotherapeutic target in various cancers (solid and hematopoietic tumors). CD226 is a transmembrane receptor that is part of the immunoglobulin superfamily. It is expressed by most T lymphocytes (CD8+, CD4+), by Natural Killer (NK) cells, by promoting their cytotoxicity.

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The investigators propose to prospectively analyze the frequency and phenotype (expression of CD226) of circulating immune cells before the initiation of treatment with Atezolizumab/Bevacizumab, 3 weeks after the first injection and its variation to determine whether this biomarker could predict the response to the treatment.

The group in the trial

  • patients with hepatocellular carcinoma

    Patients with an indication for treatment with Atezolizumab / Bevacizumab for the management of an advanced disciplinary hepatocellular carcinoma in a multidisciplinary consultation meeting.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessment of Circulating Immune Cells as a Prognostic Factor in Patients With Advanced Hepatocellular Carcinoma Treated With Immunotherapy
Record updated
18 December 2025