Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— PAI²HCC  

Official title:

Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04892810
• Other study ID #: Grenoble University Hospital
• Status: Not yet recruiting
• Start date: May 31, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Grenoble
• Contact: Julien GUELFI, PH
• Phone: 04 76 76 89 09
• Email: JGhelfi[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven HCC for less than 3 months before ablation

• Decision of ablation treatment in multidisciplinary meeting

Exclusion Criteria:

• Fibrolamellar HCC

• Hepatocholangiocarcinoma

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Percutaneous ablation
Hepatic Percutaneous Ablation with radiofrequency or microwave

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate early induced immunomodulation after RFA in HCC patients	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
Secondary	To evaluate early induced immunomodulation after MWA in HCC patients	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