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OpenTrials
Completed

NCT Number: NCT04892810

Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Grenoble, 38043, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Fibrolamellar HCC
  • Hepatocholangiocarcinoma

Treatment and study plan

Percutaneous ablation

Procedure

Hepatic Percutaneous Ablation with radiofrequency or microwave

Primary outcomes

  1. 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)

Secondary outcomes

  1. To evaluate early induced immunomodulation after RFA in HCC patients

    Time frame: 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)

  2. To evaluate early induced immunomodulation after MWA in HCC patients

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: PAI²HCC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 19, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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