Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunochemotherapy combined with antiangiogenic.
- Who it may be relevant to
- Registry conditions: Liver Cancer, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Immunophenotype of Peripheral Blood Mononuclear Cells to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
Overview
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.
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.
Interventions
- Drug Immunochemotherapy combined with antiangiogenic
Immunochemotherapy combined with antiangiogenic
Primary outcome measures
- To find predictive biomarkers of response to immunotherapy in HCC [Time frame: at 3 month]
Secondary outcome measures (1)
- To compare the transcriptomic signatures of PBMC of responders and non-responders [Time frame: At 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- IRCCS-Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06777628 · Immunecheck