Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma (PAI²HCC)

May 14, 2021 updated by: University Hospital, Grenoble
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 40 years old that can benefit for ablation (either RFA or MWA) for HCC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RFA
Patient with HCC and decision of treatment with ablation
Procedure: Percutaneous ablation
Hepatic Percutaneous Ablation with radiofrequency or microwave
MWA
Patient with HCC and decision of treatment with ablation
Procedure: Percutaneous ablation
Hepatic Percutaneous Ablation with radiofrequency or microwave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one month
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)
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 31, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Grenoble University Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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