A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06490757
Phase
PHASE2
Status
Recruiting
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Conditions

  • Inflammatory Hepatocellular Adenoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    An ancillary study will be performed in a subgroup of 12 patients to assess the variation of the results of PET-CT with 18FDG from baseline to 3 months. The variation of tumor features assessed by PET-CT with 18FDG after three months of treatment, will be assessed. The median value of the SUV max and tumor to non-tumor ratio of the SUV max value for each HCA lesion between the PET CT with 18FDG performed at baseline and after 3 months of treatment will be assessed.

Study Details

Hepatocellular adenomas (HCA) are tumors rare benign hepatic infections that develop on a liver normal and in young women taking a estrogen-based contraception. The main molecular subgroup of AHCs is the AHC subgroup inflammatory, which are associated with a risk of bleeding from the tumor and malignant transformation. Therefore, most of women with large inflammatory AHC (\>5 cm) require liver resection which can be associated with morbidity and aesthetic problems, and rarely to mortality. On the basis of the knowledge of the molecular classification of AHCs humans and preclinical data testing the JAK1/2 inhibitors, we hypothesize that a short duration of treatment with the inhibitor of JAK1/2 (baricitinib) may be effective in patients with large inflammatory AHC size.

Key Dates

Start date
Oct 2, 2024
Status verified
Oct 2025
Primary completion
Sep 2, 2028
Completion
Sep 2, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Ancillary study
    PET CT with 18 FDG will be performed in 12 patients in selected centers (Avicenne hospital, Beaujon hospital, Henri Mondor hospital, Bordeaux hospital, Paul brousse hospital, Saint Antoine hospital with nuclear medicine department available and should be done at baseline and 3 months (+/- one week).

Primary Outcome Measure

The principal outcome is to demonstrate that the combination of an experimental procedure to the standard of care lead to a significant decrease in size of large inflammatory HCA at imaging [ Time Frame: 6 month ]

Central Contacts