NCT07273708Recruiting
Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 15 Mar 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07273708
What you commit to
- Study type: Observational
- Planned participants: 20
- From 15 Mar 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Life expectancy of \<12 months due to concomitant diseases
- Ongoing drug abuse
Other illness
- Active or history of autoimmune disease or immune deficiency on inflammatory chronic diseases
- evidence or history of positive HIV test
Age
- History of malignancy other than HCC within 3 years prior to study entry with the following exception:
- Completely resected malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate 90%) and without evidence of recurrence for \> 3 years prior to study entry
- adequately treated non-melanoma skin carcinoma or lentigo maligna without evidence of metastases.
- adequately treated carcinoma in situ of the cervix without evidence of recurrence
- localised prostate cancer
- adequately treated non invasive or in situ urothelial cancers
Other
- inability to comply with the study protocol, in the investigator's judgment
Who the study is looking for
- diagnosis of advanced HCC treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treament
- age ≥18 and \<90 years at time of signing informed consent
- Signed Informed Consent Form
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.