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

104 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 treatments. This test aims to support imaging studies by identifying early signs of treatment effectiveness, ruling out false progression, and detecting when the treatment might stop working. The study also compares gene expression patterns in immune cells between patients who respond to treatment and those who do not. Participants with advanced HCC undergoing immunotherapy combined with antiangiogenic drugs will provide blood samples to assess specific immune cell markers such as CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, and others. Researchers will analyze peripheral blood mononuclear cells (PBMC) through RNA sequencing and validate these findings using RT-PCR in separate patient groups. This observational study does not involve assigning treatments but monitors patients receiving standard immunochemotherapy. During the study, participants will have their blood collected and undergo laboratory tests alongside their usual treatment and follow-up visits at the medical center. Researchers will measure immune biomarkers to predict response to immunotherapy at three months and compare gene expression between responders and non-responders. The study participation is expected to last through the treatment and follow-up period, providing valuable data to enhance early prediction of treatment response in HCC patients.

CONDITIONS

Brief 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)
  • Undergoing 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 3 months

Participants undergoing immunotherapy for advanced hepatocellular carcinoma are observed with blood samples collected to assess immune biomarkers and transcriptomic signatures.

Regular blood sample collections during immunotherapy

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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