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

Recruiting

• Conditions: Liver Cancer, Adult
• Interventions: Drug: Immunochemotherapy combined with antiangiogenic

• Registration Number: NCT06777628
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-15
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-10-15
• Study Completion: 2028-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC patients	Immunochemotherapy combined with antiangiogenic	Patients with advanced HCC undergoing immunotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

IRCCS-Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Laura Gramantieri, Italy