Phase 2 Study of Baricitinib, a JAK1 Inhibitor, for Treating Large Inflammatory Hepatocellular Adenomas

What this Trial Is About

Researchers are investigating a treatment for large inflammatory hepatocellular adenomas HCA, which are rare benign liver tumors mainly affecting young women using estrogen-based contraception. These tumors carry risks of bleeding and malignant transformation, often requiring liver surgery that can cause complications and cosmetic issues. This phase 2 open-label trial explores whether short-term use of the JAK12 inhibitor baricitinib can reduce tumor size and potentially avoid surgery. Participants will receive baricitinib, a drug that targets the JAKSTAT pathway activated in inflammatory HCA tumors. An ancillary study in 12 patients will use PET CT scans with 18 FDG to monitor tumor changes from baseline to 3 months. The main treatment period involves assessing tumor size changes at 3 and 6 months to determine response. Follow-up will continue up to 24 months to track surgery need, tumor growth, symptom occurrence, and adverse events. During the study, participants will undergo imaging assessments including PET CT and standard scans at scheduled intervals. Researchers will evaluate tumor size using RECIST 1.1 criteria, monitor for bleeding or malignant transformation, and record any side effects from baricitinib. Safety and long-term outcomes will be observed through visits at multiple time points up to two years after treatment starts.

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