Clinical trial · Observational
Single-Cell Profiling of Liver-infiltrating Immune Cells of Patients with NASH- and Virus-related HCC: Implications for Immunotherapy
NCT06899763CI-TRIAL-000878061003rcr2022_72completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to learn about the the immune landscape of HCC arising from different etiology, such as MASLD and viral hepatitis, at single cell level. The main question it aims to answer is: Which are the immune signatures and pathways linked to MASLD- or virus-related HCC and what could be the best targets for immunotherapy?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCV_HCC | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| MASLD-HCC | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- patients with MASLD-related HCC
- description
- The cohort is composed of patients with MASLD-related HCC. MASLD, previously termed non-alcoholic fatty liver disease (NAFLD), is defined as steatotic liver disease (SLD) in the presence of one or more cardiometabolic risk factor(s) and the absence of harmful alcohol intake (Rinella ME, Lazarus JV, Ratziu V, et al. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023;79(6):1542-1556. doi:10.1016/j.jhep.2023.06.003).
- label
- patients with HCV-related HCC
- description
- The cohort is composed of patients with HCV-related HCC.
Primary outcomes (1)
- measure
- Identification of differentially expressed genes (DEGs) among different patients in the various cellular clusters identified, using scRNA-seq.
- timeFrame
- until the end of the study, approximatively 2 years
- description
- scRNA-seq will provide data to perform cell type annotation. For each cluster DEG will be identify through bioinformatic analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion criteria: * HCV-related HCC or MASLD-related HCC * age: ≥ 18 years, ≤ 90 years * Signature of the informed consent Esclusion criteria: * Concomitant pathologies with a life expectancy of less than 12 months * Autoimmune or chronic inflammatory diseases * Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors, tyrosine kinase inhibitors, or anti-VEGF therapies * Other ongoing extrahepatic malignancies or those diagnosed within the last 3 years, except for tumors resected with curative intent and with no evidence of disease recurrence for \>3 years prior to the signing of informed consent, and considered at low risk of recurrence * HIV infection * Lack of patient cooperation and failure to sign the informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.