NCT07273708

Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The study aims to analyze blood samples from patients with advanced hepatocellular carcinoma who are receiving systemic treatment with immunotherapy. The objective is to determine whether treatment exposure leads to changes in the transcriptomic patterns of peripheral blood mononuclear cells (PBMCs), if these changes are associated with treatment response, and whether certain pre-treatment transcriptomic signatures can predict response to treatment. As an exploratory objective, PBMCs derived from patients exposed to immune checkpoint inhibitors will be co-cultured with their paired tumor cells in organoid cultures. This aims to assess whether these preclinical 3D models correlate with clinical outcomes.

Detailed description

The primary pivotal objective of the study is to analyse the single cell transcriptome of peripheral blood mononuclear cells (PBMCs) in patients with HCC treated with immunotherapy to define if treatment exposure determines transcriptomic pattern changes and if some of these changes are associated with treatment response. The secondary objective of the study is to investigate if some pre-treatment transcriptome signature of PBMCs is predictive of response and long-lasting response to treatment. As an exploratory objective, the study investigators will analyse the interaction between patients' peripheral immune cells previously exposed to immune check-point inhibitors and their paired tumour cells in the organoid cultures.

Conditions

• Advanced HCC Treated by Systemic Immunotherapy

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: Italy