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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Liver Cancer, Adult

Treatments

Drug: Immunochemotherapy combined with antiangiogenic

Study type

Observational

Funder types

Other

Identifiers

Immunecheck

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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