OncoMatch/Clinical Trials/NCT06490757
A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
Is NCT06490757 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Baricitinib for inflammatory hepatocellular adenoma.
Treatment: Baricitinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: CRP overexpression
inflammatory subtype confirmed at histology and immunohistochemistry (CRP or SAA immunohistochemistry)
Required: SAA overexpression
inflammatory subtype confirmed at histology and immunohistochemistry (CRP or SAA immunohistochemistry)
Excluded: CTNNB1 mutation in exon 3
mutations in exon 3 of CTNNB1 at molecular biology (except in this tumor is considered as unresectable) at the pathological reviewing
Prior therapy
Cannot have received: immunosuppressive treatment (methotrexate, azathioprine, mycophenolate)
Exception: corticosteroid
Cannot have received: biologic therapy (etanercept, infliximab, certolizumab, adalimumab, golimumab, anakinra, tocilizumab, abatacept, ustekinumab, rituximab, belimumab)
Lab requirements
Blood counts
Thrombocytopenia < 100 000/mm3; Neutropenia < 1200/mm3; Lymphopénia < 750/mm3; Anemia < 9 g/dl
Kidney function
Renal impairment with estimated creatinine clearance < 50 ml/mn (Cockroft and Gault formula) [excluded]
Liver function
ASAT > 5 times upper fold of the normal or ALAT > 5 times upper fold of the normal or total bilirubin > upper 1.5 fold of the normal; hepatic impairment defined by Child Pugh B or C [excluded]
Cardiac function
Screening ECG abnormalities that are clinically significant and indicate an unacceptable risk; Past history of acute myocardial infection or unstable angina; Past history of stroke (including transient ischemic attack); Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; Past history NYHA class III or IV congestive heart failure; Second or third atrioventricular block
ASAT > 5 times upper fold of the normal or ALAT > 5 times upper fold of the normal or total bilirubin > upper 1.5 fold of the normal; hepatic impairment defined by Child Pugh B or C; Renal impairment with estimated creatinine clearance < 50 ml/mn (Cockroft and Gault formula); Thrombocytopenia < 100 000/mm3; Neutropenia < 1200/mm3; Lymphopénia < 750/mm3; Anemia < 9 g/dl; Screening ECG abnormalities that are clinically significant and indicate an unacceptable risk; Past history of acute myocardial infection or unstable angina; Past history of stroke (including transient ischemic attack); Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment; Past history NYHA class III or IV congestive heart failure; Second or third atrioventricular block
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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