RecruitingPhase 2NCT06490757

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

Enrollment

25 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Hepatocellular Adenoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a JAK1 inhibitor drug (a type of anti-inflammatory medication) as a non-surgical treatment for large inflammatory hepatocellular adenomas (benign liver tumors). These tumors are rare but can carry a risk of bleeding or turning cancerous if they grow large. **You may be eligible if...** - You are a woman (or a man with a non-resectable adenoma) with a confirmed inflammatory hepatocellular adenoma - You have at least one tumor measuring more than 5 cm - The tumor type has been confirmed by tissue biopsy and specialized staining tests **You may NOT be eligible if...** - Your tumor is a different subtype (non-inflammatory) - You have significant liver disease (like cirrhosis) - You have other serious health conditions or are taking medications that could interfere - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaricitinib

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.

Locations(1)

NAULT

Bobigny, France

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NCT06490757