Advanced HCC Treated by Systemic ImmunotherapyHCC RNA-seqNCT07273708
Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
An observational study of Advanced HCC Treated by Systemic Immunotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced HCC Treated by Systemic Immunotherapy
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treament for advanced HCC
Who may be able to join
- 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
Who cannot join
- Life expectancy of <12 months due to concomitant diseases
- Active or history of autoimmune disease or immune deficiency on inflammatory chronic diseases
- Ongoing drug abuse
- 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.
Show all 11Show fewer
- adequately treated carcinoma in situ of the cervix without evidence of recurrence
- localised 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, in the investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Salvatore Corallo, MD, +39 0382501557, s.corallo@smatteo.pv.it
About this study
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.
Read the 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.
- Keywords
- HCC Organoids, HCC PBMCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort | Patients treated withi immune-check point inhibitor-based combinations as first-line treatment for advanced HCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy pre-therapy (T0) and the 3 months post-therapy (T3) to define if a difference between the two time points exists.
The single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy will be analised at two type points: before starting therapy(T0), and the 3 months post-therapy (T3). The difference of single cell profiling of the two paired time-points will be analysed.
Measured: From enrollment untill 3 months after treatment start, (up to 120 days from study inclusion)
Secondary outcomes (2)
Correlation between transcriptome signature at baseline and treatment outcomes.
To define if there is a correlation between baseline transcriptome signatures and treatment outcomes (duration of response, median progression-free survival, median overall survival)
Measured: From enrollment to the time of best response to treatment, up to 24 months from enrollement
Correlation between baseline gene clusters and treatment responses
To identify baseline gene clusters that correlats with higher respose rates
Measured: From enrollment to the time of best response, up to 24 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Mar 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HCC Treated by Systemic ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Corallo, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273708
- Sponsor's protocol ID
- 0014773/25
- Acronym
- HCC RNA-seq
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending privacy protection evaluation
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of an Immune Single Cell Transcriptomic Profile of Responder and Non-responder Hepatocellular Carcinoma Patients Treated With Immune-checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07273708
- Acronym / sponsor ID
- HCC RNA-seq / 0014773/25
- Keywords
- HCC Organoids, HCC PBMCs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort | – | –Patients treated withi immune-check point inhibitor-based combinations as first-line treatment for advanced HCC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with atezolizumab plus bevacizumab or tremelimumab single dose plus durvalumab (STRIDE regimen) as first-line treament for advanced HCC
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Life expectancy of <12 months due to concomitant diseases
- Active or history of autoimmune disease or immune deficiency on inflammatory chronic diseases
- Ongoing drug abuse
- History of malignancy other than HCC within 3 years prior to study entry with the following exception:
- evidence or history of positive HIV test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of the single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy pre-therapy (T0) and the 3 months post-therapy (T3) to define if a difference between the two time points exists.
Time frame: From enrollment untill 3 months after treatment start, (up to 120 days from study inclusion)
The single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy will be analised at two type points: before starting therapy(T0), and the 3 months post-therapy (T3). The difference of single cell profiling of the two paired time-points will be analysed.
2 secondary outcomes
Correlation between transcriptome signature at baseline and treatment outcomes.
Time frame: From enrollment to the time of best response to treatment, up to 24 months from enrollement
Correlation between baseline gene clusters and treatment responses
Time frame: From enrollment to the time of best response, up to 24 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided. Pending privacy protection evaluation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced HCC Treated by Systemic Immunotherapy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Corallo (+39 0382501557, s.corallo@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the single cell profiling of peripheral blood mononuclear cells in patients with HCC treated with immunotherapy pre-therapy (T0) and the 3 months post-therapy (T3) to define if a difference between the two time points exists. (time frame: From enrollment untill 3 months after treatment start, (up to 120 days from study inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.