Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma (Immunecheck)

January 14, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Immunophenotype of Peripheral Blood Mononuclear Cells 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Laura Gramantieri
      • Bologna, Laura Gramantieri, Italy, 40138
        • Recruiting
        • IRCCS-Azienda Ospedaliero-Universitaria di Bologna
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with advanced hepatocellular carcinoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients
Patients with advanced HCC undergoing immunotherapy
Drug: Immunochemotherapy combined with antiangiogenic
Immunochemotherapy combined with antiangiogenic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Laura Gramantieri, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2028

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Immunecheck

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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