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NCT Number: NCT06777628

Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:

* predicting response to immune-therapeutic regimens in HCC in the early phase of treatment, * to rule out pseudo-progression, * to early predict the escape from effectiveness of treatment.

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Key information

Conditions

Liver Cancer, Adult Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS-Azienda Ospedaliero-Universitaria di Bologna

Bologna, Laura Gramantieri, 40138, Italy

Location status: Recruiting

Location contact

Laura Gramantieri, MD

CONTACT

[email protected]

+390512142214

About this study

  • To assess the accuracy of biomarkers from an immunophenotypic test (CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, CD8+PD1+, CD8+PDL1+ peripheral lymphocyte populations and circulating granulocytes) in predicting the response to immuno-therapy in patients affected by hepatocellular carcinoma (HCC).
  • To compare the transcriptomic signatures of peripheral blood mononuclear cells (PBMC) of responders and non-responders (assessed at the first imaging study).

RNAseq data will be validated by RT-PCR in independent prospective cohorts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years
  • diagnosis of HCC
  • execution of laboratory tests and subsequent treatments and follow-up at our center.
  • obtained written informed consent to the study participation

Exclusion criteria

  • immune-related concomitant diseases
  • HIV infection

Treatment and study plan

Immunochemotherapy combined with antiangiogenic

Drug

Immunochemotherapy combined with antiangiogenic

Primary outcomes

  1. To find predictive biomarkers of response to immunotherapy in HCC

    Time frame: at 3 month

    Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria

Secondary outcomes

  1. To compare the transcriptomic signatures of PBMC of responders and non-responders

    Time frame: At 3 months

    Tumor response according to RECIST 1.1 criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Gramantieri, MD

CONTACT

[email protected]

0512142579

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Immunophenotype of Peripheral Blood Mononuclear Cells to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma

Acronym: Immunecheck

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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