Actively Recruiting
Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-12-09
20
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced hepatocellular carcinoma treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treatment
- Age 18 to less than 90 years at time of signing informed consent
- Signed Informed Consent Form
You will not qualify if you...
- Life expectancy less than 12 months due to other diseases
- Active or history of autoimmune disease, immune deficiency, or chronic inflammatory diseases
- Ongoing drug abuse
- History of other malignancy within 3 years prior to study entry except:
- Completely resected malignancies with negligible risk of metastasis or death and no recurrence for over 3 years
- Adequately treated non-melanoma skin cancer or lentigo maligna without metastases
- Adequately treated carcinoma in situ of the cervix without recurrence
- Localized prostate cancer
- Adequately treated non-invasive or in situ urothelial cancers
- Evidence or history of positive HIV test
- Inability to comply with the study protocol as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
Research Team
S
Salvatore Corallo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here