NCT06490757 A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
| NCT ID | NCT06490757 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Inflammatory Hepatocellular Adenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2028-09-02 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: * Women (or male with inflammatory HCA considered as non resectable whatever the size of the HCA) * Written informed consent for participation in study * Histologically proven hepatocellular adenoma (confirmed by a centralized reviewing) with available FFPE * At least one HCA of inflammatory subtype confirmed at histology and immunohistochemistry (CRP or SAA immunohistochemistry) by a centralized reviewing * At least one HCA of more than 5 cm at imaging of inflammatory subtype (if the HCA of more than 5 cm is not the same HCA proved as inflammatory at histology this HCA should harbored the same imaging features than the HCA with available histology) for women. * Diagnosed at histology over the last 5 years * Absence of desire of pregnancy while treated by baricitinib and for at least 4 weeks following the last dose of investigational product * Females of childbearing potential should have a contraception (without estrogen) when engaging in sexual intercourse with a