Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Percutaneous ablation

• Registration Number: NCT04892810
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-14
• Last Update Submitted: 2021-05-14
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19
• Study Start: 2021-05-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Histologically proven HCC for less than 3 months before ablation
• Decision of ablation treatment in multidisciplinary meeting

Exclusion Criteria

• Fibrolamellar HCC
• Hepatocholangiocarcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RFA	Percutaneous ablation	Patient with HCC and decision of treatment with ablation
MWA	Percutaneous ablation	Patient with HCC and decision of treatment with ablation

Primary Outcome Measures

Name	Time	Method
To compare induced immunomodulation by RFA and MWA in HCC patients	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)

Secondary Outcome Measures

Name	Time	Method
To evaluate early induced immunomodulation after RFA in HCC patients	one month	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)
To evaluate early induced immunomodulation after MWA in HCC patients	one month	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)