Hepatocellular CarcinomaPAI²HCCNCT04892810
Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Percutaneous ablation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 10 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Adult, Older adult
Study population: Patients older than 40 years old that can benefit for ablation (either RFA or MWA) for HCC
Who may be able to join
- Histologically proven HCC for less than 3 months before ablation
- Decision of ablation treatment in multidisciplinary meeting
Who cannot join
- Fibrolamellar HCC
- Hepatocholangiocarcinoma
Trial locations and contacts
1 site in 1 country.
About this study
This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Percutaneous ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous ablationProcedure or surgery
Hepatic Percutaneous Ablation with radiofrequency or microwave
| Study group | Role | What they receive |
|---|---|---|
| RFA | Patient with HCC and decision of treatment with ablation Receives: Procedure: Percutaneous ablation | |
| MWA | Patient with HCC and decision of treatment with ablation Receives: Procedure: Percutaneous ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare induced immunomodulation by RFA and MWA in HCC patients
Comparison of modulation of immune cells (frequency, activity, function) between the two groups. Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) before and after the treatment (day 0, day 2, day 7, day 30)
Measured: one month
Secondary outcomes (2)
To evaluate early induced immunomodulation after RFA in HCC patients
Differences of frequencies, activities, functions of immune cells before and after the RFA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T)
Measured: one month
To evaluate early induced immunomodulation after MWA in HCC patients
Differences of frequencies, activities, functions of immune cells before and after the MWA treatment (day 0, day 2, day 7, day 30). Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start3 Feb 2022
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892810
- Sponsor's protocol ID
- Grenoble University Hospital
- Acronym
- PAI²HCC
- Status last verified
- Jul 2026
- First submitted
- 3 May 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04892810
- Acronym / sponsor ID
- PAI²HCC / Grenoble University Hospital
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 19 May 2021 (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.
This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA | – | Procedure: Percutaneous ablationPatient with HCC and decision of treatment with ablation |
| MWA | – | Procedure: Percutaneous ablationPatient with HCC and decision of treatment with ablation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 40 years old that can benefit for ablation (either RFA or MWA) for HCC
Key inclusion criteria (2 listed)
- Histologically proven HCC for less than 3 months before ablation
- Decision of ablation treatment in multidisciplinary meeting
Key exclusion criteria (2 listed)
- Fibrolamellar HCC
- Hepatocholangiocarcinoma
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 |
|---|---|---|
| Percutaneous ablationHepatic Percutaneous Ablation with radiofrequency or microwave | Procedure or surgery | MWA, RFA |
Primary outcome
To compare induced immunomodulation by RFA and MWA in HCC patients
Time frame: one month
Comparison of modulation of immune cells (frequency, activity, function) between the two groups. Study of immune cells will include T cells with immune checkpoints molecules (PD-1+ CD8+ T, 4-1BB+ CD8+ T, LAG-3+ CD8+ T, Tim-3+ CD8+ T, COS+ CD8+ T) before and after the treatment (day 0, day 2, day 7, day 30)
2 secondary outcomes
To evaluate early induced immunomodulation after RFA in HCC patients
Time frame: one month
To evaluate early induced immunomodulation after MWA in HCC patients
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatocellular Carcinoma, run by University Hospital, Grenoble at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 22 Jul 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare induced immunomodulation by RFA and MWA in HCC patients (time frame: one 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 22 Jul 2026.