Actively Recruiting
A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-26
25
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women or males with non-resectable inflammatory hepatocellular adenoma
- Written informed consent to participate
- Histologically confirmed hepatocellular adenoma with available tissue samples
- At least one inflammatory subtype adenoma confirmed by histology and immunohistochemistry
- At least one inflammatory adenoma larger than 5 cm on imaging for women
- Diagnosis made within the last 5 years
- No desire for pregnancy during treatment and for 4 weeks after
- Women of childbearing potential must use non-estrogen contraception during treatment and for 4 weeks after
- Men engaging in sexual intercourse must use contraception during treatment and for 4 weeks after
- Past varicella zoster virus infection or vaccination at least 4 weeks before inclusion
- Have medical insurance coverage
You will not qualify if you...
- Age under 18 or over 65 years
- Pregnant or breastfeeding women
- Currently using estrogen-based contraception
- Receiving state medical aid (AME)
- Current or recent serious infections within 4 weeks prior to inclusion
- Significant ECG abnormalities posing risk
- Low blood counts: thrombocytopenia, neutropenia, lymphopenia, anemia below specified thresholds
- Use of immunosuppressive drugs except corticosteroids
- Recent use of certain biologic therapies within specified time frames
- Liver enzyme levels or bilirubin above defined limits
- Severe liver impairment (Child Pugh B or C)
- Active or latent tuberculosis without adequate treatment
- Renal impairment with creatinine clearance below 50 ml/min
- Major surgery within 8 weeks prior or planned during study posing risk
- History of lymphoproliferative disease, heart attack, stroke, severe heart failure, thromboembolic events
- Uncontrolled high blood pressure
- Significant smoking history over 15 pack years
- Certain heart conduction blocks
- Active cancer or recent history of cancer with exceptions
- Recent or complicated herpes zoster infection
- Exposure to live vaccines within 12 weeks prior to inclusion
- Active or chronic hepatitis B, C, or HIV infection
- Under guardianship or deprived of liberty
- Participation in another interventional trial
- Allergy to baricitinib or its ingredients
- Past organ transplantation
- Surgical indication for adenoma resection in men unless deemed unresectable
- Activation of Wnt/B-catenin pathway or malignant transformation signs
- Other reasons approved by tumor board
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Trial Site Locations
Total: 1 location
1
NAULT
Bobigny, France, 93000
Actively Recruiting
Research Team
J
Jean Charles NAULT, PUPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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