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.
Study Type
OBSERVATIONAL
Enrollment
100
Immunochemotherapy combined with antiangiogenic
IRCCS-Azienda Ospedaliero-Universitaria di Bologna
Bologna, Laura Gramantieri, Italy
RECRUITINGTo find predictive biomarkers of response to immunotherapy in HCC
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
Time frame: at 3 month
To compare the transcriptomic signatures of PBMC of responders and non-responders
Tumor response according to RECIST 1.1 criteria
Time frame: At 3 months
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