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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06777628

Acronym

Immunecheck

Enrollment

100

Registered

2025-01-16

Start date

2024-09-15

Completion date

2028-10-15

Last updated

2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Adult

Keywords

immunophenotype, HCC patients, immunotherapy

Brief summary

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

DRUGImmunochemotherapy combined with antiangiogenic

Immunochemotherapy combined with antiangiogenic

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* immune-related concomitant diseases * HIV infection

Design outcomes

Primary

Measure	Time frame	Description
To find predictive biomarkers of response to immunotherapy in HCC	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

Secondary

Measure	Time frame	Description
To compare the transcriptomic signatures of PBMC of responders and non-responders	At 3 months	Tumor response according to RECIST 1.1 criteria

Countries

Italy

Contacts

Primary ContactLaura Gramantieri, MD

laura.gramantieri@aosp.bo.it0512142579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026