Liver Cancer, AdultImmunecheckNCT06777628
Immunophenotype of PBMC to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
An observational study of Liver Cancer, Adult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for: predicting response to immune-therapeutic regimens in HCC in the early phase of treatment, to rule out pseudo-progression, to early predict the escape from effectiveness of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult
- What is being tested?
- Immunochemotherapy combined with antiangiogenic
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2024to 15 Oct 2028
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with advanced hepatocellular carcinoma
Who may be able to join
- age ≥ 18 years
- diagnosis of HCC
- execution of laboratory tests and subsequent treatments and follow-up at our center.
- obtained written informed consent to the study participation
Who cannot join
- immune-related concomitant diseases
- HIV infection
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
IRCCS-Azienda Ospedaliero-Universitaria di Bologna
Bologna, Laura Gramantieri, 40138
Laura Gramantieri, MD, +390512142214, laura.gramantieri@aosp.bo.it
About this study
Official title: Immunophenotype of Peripheral Blood Mononuclear Cells to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
The study is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:
- predicting response to immune-therapeutic regimens in HCC in the early phase of treatment,
- to rule out pseudo-progression,
- to early predict the escape from effectiveness of treatment.
Read the detailed description
- To assess the accuracy of biomarkers from an immunophenotypic test (CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, CD8+PD1+, CD8+PDL1+ peripheral lymphocyte populations and circulating granulocytes) in predicting the response to immuno-therapy in patients affected by hepatocellular carcinoma (HCC).
- To compare the transcriptomic signatures of peripheral blood mononuclear cells (PBMC) of responders and non-responders (assessed at the first imaging study).
RNAseq data will be validated by RT-PCR in independent prospective cohorts.
- Conditions
- Liver Cancer, Adult
- Being tested
- Immunochemotherapy combined with antiangiogenic
- Keywords
- immunophenotype, HCC patients, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunochemotherapy combined with antiangiogenicDrug
Immunochemotherapy combined with antiangiogenic
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | Patients with advanced HCC undergoing immunotherapy Receives: Drug: Immunochemotherapy combined with antiangiogenic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find predictive biomarkers of response to immunotherapy in HCC
Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria
Measured: at 3 month
Secondary outcomes (1)
To compare the transcriptomic signatures of PBMC of responders and non-responders
Tumor response according to RECIST 1.1 criteria
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Sep 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Gramantieri, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777628
- Sponsor's protocol ID
- Immunecheck
- Acronym
- Immunecheck
- Status last verified
- Sep 2024
- First submitted
- 28 Nov 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotype of Peripheral Blood Mononuclear Cells to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06777628
- Acronym / sponsor ID
- Immunecheck / Immunecheck
- Conditions
- Liver Cancer, Adult
- Keywords
- immunophenotype, HCC patients, immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 16 Jan 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 is aimed to test the performance of a simple, easy, reproducible cytofluorimetric assay to complement imaging studies for:
- predicting response to immune-therapeutic regimens in HCC in the early phase of treatment,
- to rule out pseudo-progression,
- to early predict the escape from effectiveness of treatment.
Detailed description
- To assess the accuracy of biomarkers from an immunophenotypic test (CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, CD8+PD1+, CD8+PDL1+ peripheral lymphocyte populations and circulating granulocytes) in predicting the response to immuno-therapy in patients affected by hepatocellular carcinoma (HCC).
- To compare the transcriptomic signatures of peripheral blood mononuclear cells (PBMC) of responders and non-responders (assessed at the first imaging study).
RNAseq data will be validated by RT-PCR in independent prospective cohorts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Drug: Immunochemotherapy combined with antiangiogenicPatients with advanced HCC undergoing immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced hepatocellular carcinoma
Key inclusion criteria (4 listed)
- age ≥ 18 years
- diagnosis of HCC
- execution of laboratory tests and subsequent treatments and follow-up at our center.
- obtained written informed consent to the study participation
Key exclusion criteria (2 listed)
- immune-related concomitant diseases
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunochemotherapy combined with antiangiogenicImmunochemotherapy combined with antiangiogenic | Drug | HCC patients |
Primary outcome
To find predictive biomarkers of response to immunotherapy in HCC
Time frame: at 3 month
Sensitivity and specificity of CD8+, PD1+, PD-L1+, CTLA4+, LAG3+, TIGIT+, CD8+PD1+, CD8+PDL1+ peripheral lymphocytes and granulocytes for tumor response prediction according to RECIST 1.1 criteria
1 secondary outcome
To compare the transcriptomic signatures of PBMC of responders and non-responders
Time frame: At 3 months
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 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Laura Gramantieri principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Liver Cancer, Adult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 4 inclusion and 2 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 16 Jan 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 Laura Gramantieri, MD (0512142579, laura.gramantieri@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find predictive biomarkers of response to immunotherapy in HCC (time frame: at 3 month). 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 16 Jan 2025.