Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04892810

Acronym

PAI²HCC

Enrollment

Registered

2021-05-19

Start date

2022-02-03

Completion date

2026-06-10

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

PROCEDUREPercutaneous ablation

Hepatic Percutaneous Ablation with radiofrequency or microwave

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* Fibrolamellar HCC * Hepatocholangiocarcinoma

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026