Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma
PAI²HCC
1 other identifier
observational
20
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
May 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 19, 2021
May 1, 2021
1.1 years
May 3, 2021
May 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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)
one month
Secondary Outcomes (2)
To evaluate early induced immunomodulation after RFA in HCC patients
one month
To evaluate early induced immunomodulation after MWA in HCC patients
one month
Study Arms (2)
RFA
Patient with HCC and decision of treatment with ablation
MWA
Patient with HCC and decision of treatment with ablation
Interventions
Eligibility Criteria
Patients older than 40 years old that can benefit for ablation (either RFA or MWA) for HCC
You may qualify if:
- Histologically proven HCC for less than 3 months before ablation
- Decision of ablation treatment in multidisciplinary meeting
You may not qualify if:
- Fibrolamellar HCC
- Hepatocholangiocarcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2021
First Posted
May 19, 2021
Study Start
May 31, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
May 19, 2021
Record last verified: 2021-05