Actively Recruiting

Age: 18Years +
All Genders
ID06777628

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-16

100

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a simple and reproducible blood test called a cytofluorimetric assay to help predict how patients with hepatocellular carcinoma (HCC), a type of liver cancer, respond to immunotherapy. This test aims to complement imaging studies by identifying early treatment responses, distinguishing true progression from pseudo-progression, and predicting when the treatment may stop being effective. The study also examines specific immune cell markers and gene expression in blood cells to understand differences between patients who respond to treatment and those who do not. Participants will receive immunochemotherapy combined with antiangiogenic drugs as part of their treatment. The study measures immune cells in the blood, including CD8+, PD1+, PD-L1+, CTLA4+, LAG3+ lymphocytes, and circulating granulocytes, to assess their role in treatment response. Additionally, transcriptomic (RNA) analyses of peripheral blood mononuclear cells will be performed and validated in independent groups to identify biomarkers linked to therapy outcomes. Throughout the study, participants will undergo laboratory tests and follow-up visits at the study center. Researchers will collect blood samples to perform immunophenotypic testing and gene expression analysis at baseline and during treatment. The main outcome is to find predictive biomarkers of response to immunotherapy within the first three months. The study requires written informed consent and continuous monitoring to ensure safety and accurate data collection during treatment and follow-up.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of hepatocellular carcinoma (HCC)
  • Ability to have laboratory tests, treatments, and follow-up at the study center
  • Provided written informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Presence of immune-related concomitant diseases
  • HIV infection

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS-Azienda Ospedaliero-Universitaria di Bologna

Bologna, Laura Gramantieri, Italy, 40138

Actively Recruiting

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Research Team

L

Laura Gramantieri, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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