NCT06777628

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer, Adult

Interventions

Type	Name	Description
DRUG	Immunochemotherapy combined with antiangiogenic	Immunochemotherapy combined with antiangiogenic

Timeline

• Start date: 2024-09-15
• Primary completion: 2026-10-15
• Completion: 2028-10-15
• First posted: 2025-01-16
• Last updated: 2025-01-16

Locations

1 site across 1 country: Italy