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

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.

• 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.

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