A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
NCT ID: NCT06490757
Last Updated: 2025-12-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-02
Study Completion Date
2028-09-02
Brief Summary
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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.
Detailed Description
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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, characterized by activation of the pathway JAK/STAT due to mutations in IL6ST, STAT3, FRK, JAK1 or GNAS, with inflammatory infiltrates at histology. Hepatocellular adenomas 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
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Inflammatory Hepatocellular Adenoma
Keywords
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Hepatocellular adenoma
Inflammatory
JAK STAT pathway
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Ancillary study
PET CT with 18 FDG will be performed in 12 patients in selected centers (Avicenne hospital, Beaujon hospital, Henri Mondor hospital, Bordeaux hospital, Paul brousse hospital, Saint Antoine hospital with nuclear medicine department available and should be done at baseline and 3 months (+/- one week).
Group Type
OTHER
Baricitinib
Intervention Type
DRUG
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.
Interventions
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Baricitinib
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.
Intervention Type
DRUG
Other Intervention Names
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fluorodésoxyglucose (18F)- Positron Emission Tomography (PET)
Eligibility Criteria
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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 male partner while treated by baricitinib and for at least 4 weeks following the last dose of investigational product. In case of oral contraception, patients should have been using it for a minimum of one month before the beginning of the treatment. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Male when engaging in sexual intercourse with a female partner shoud have a contraception while treated by baricitinib and for at least 4 weeks following the last dose of investigational product A man is considered fertile after puberty unless permanently sterile by bilateral orchiectomy
* Past infection of Varicella zona Virus confirmed by serology or vaccine against Varicella zona Virus done more than 4 weeks before the inclusion
* Coverage for medical insurance
* 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 male partner while treated by baricitinib and for at least 4 weeks following the last dose of investigational product. In case of oral contraception, patients should have been using it for a minimum of one month before the beginning of the treatment. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
* Male when engaging in sexual intercourse with a female partner shoud have a contraception while treated by baricitinib and for at least 4 weeks following the last dose of investigational product A man is considered fertile after puberty unless permanently sterile by bilateral orchiectomy
* Past infection of Varicella zona Virus confirmed by serology or vaccine against Varicella zona Virus done more than 4 weeks before the inclusion
* Coverage for medical insurance
Exclusion Criteria
* \< 18 years old and \> 65 years old
* Pregnancy or breastfeeding woman
* Ongoing estrogen-based contraception at inclusion
* Patient on AME (state medical aid)
* Have a current or recent (\<4 weeks prior to inclusion) clinically serious viral, bacterial, fungal, or parasitic infection (Note: For example, a recent viral upper respiratory tract infection or uncomplicated urinary tract infection should not be considered clinically serious).
* Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the patient's participation in the study.
* Thrombocytopenia \< 100 000/mm3
* Neutropenia \< 1200/mm3
* Lymphopénia \< 750/mm3
* Anemia \< 9 g/dl
* Concomitant use of immunosuppressive treatment such as methotrexate, azathioprine, mycophenolate (at the exception of corticosteroid)
* Have received etanercept, infliximab, certolizumab, adalimumab, golimumab, or anakinra within 12 weeks of screening; tocilizumab, abatacept, ustekinumab, rituximab, belimumab, or any other B cell targeted therapies (approved or investigational) within 24 weeks of screening; or any other biologic therapy within 4 weeks of inclusion, whichever is longer.
* 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
* Have evidence of active tuberculosis as documented by medical history, clinical symptoms, and abnormal chest x-ray at screening together with positive quantiferon or T spot test or positive culture
* Have evidence of latent TB (as documented by a positive quantiferon or T spot test, no clinical symptoms consistent with active TB, and a normal chest x-ray at screening, or as outlined below) unless patient completes at least 4 weeks of appropriate treatment prior to inclusion and agrees to complete the remainder of treatment while in the trial.
* Renal impairment with estimated creatinine clearance \< 50 ml/mn (Cockroft and Gault formula)
* Have had any major surgery within 8 weeks prior to screening or will require major
* surgery during the study that, in the opinion of the investigator in consultation with the principal investigator, would pose an unacceptable risk to the patient.
* Past history of lymphoproliferative disease
* Past history of acute myocardial infection or unstable angina
* Past history of stroke (including transient ischemic attack)
* Uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic BP (SBP), or \> 100 mm Hg diastolic BP (DBP) despite optimal antihypertensive treatment
* Past history NYHA (New York Heart Association) class III or IV congestive heart failure
* Thromboembolic event within 6 months before inclusion
* current or past long-time smokers defined by more than 15 pack years
* Second or third atrioventricular block
* Active cancer
* Past history of cancer the 5 years before the inclusion with the following exception:
* -Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study.
* -Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study.
* Have had symptomatic herpes zoster infection within 6 months prior to screening
* Have a past history of recurrent symptomatic zona (one single symptomatic zona that had occurred more than 6 months before the inclusion is not a contra-indication)
* Have a history of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia).
* Have been exposed to a live vaccine within 12 weeks prior to planned inclusion or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination that must occur \> 4 weeks prior to inclusion).
* Have active or chronic viral infection from hepatitis B virus (HBV, defined by positive aghbs), hepatitis C virus (HCV, defined by positive PCR), or human immunodeficiency virus (HIV, defined by positive serology).
* Patients under guardianship (tutelle/curatelle)
* Patient deprived of liberty under judicial or administrative decision.
* Participation in another interventional trial
* Hypersensitivity to the active substance (baricitinib) or to any of the excipients
* Past history of organ transplantation
* Surgery of the target IHCA required at diagnosis validated by a multidisciplinary tumor board during the screening process due to the following reason:
* Male with HCA accessible to liver resection (male not accessible to surgery based on a multidisciplinary tumor board evaluation could be included)
* Activation of the Wnt/B-catenin pathway at immunohistochemistry (diffuse positive glutamine synthase and/or nuclear translation of B-catenin) or mutations in exon 3 of CTNNB1 at molecular biology (except in this tumor is considered as unresectable) at the pathological reviewing
* Signs of malignant transformation in HCC (suspected by multidisciplinary tumor board based on imaging features or results of histology)
* Any other reasons validated by the multidisciplinary tumor board
* Pregnancy or breastfeeding woman
* Ongoing estrogen-based contraception at inclusion
* Patient on AME (state medical aid)
* Have a current or recent (\<4 weeks prior to inclusion) clinically serious viral, bacterial, fungal, or parasitic infection (Note: For example, a recent viral upper respiratory tract infection or uncomplicated urinary tract infection should not be considered clinically serious).
* Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the patient's participation in the study.
* Thrombocytopenia \< 100 000/mm3
* Neutropenia \< 1200/mm3
* Lymphopénia \< 750/mm3
* Anemia \< 9 g/dl
* Concomitant use of immunosuppressive treatment such as methotrexate, azathioprine, mycophenolate (at the exception of corticosteroid)
* Have received etanercept, infliximab, certolizumab, adalimumab, golimumab, or anakinra within 12 weeks of screening; tocilizumab, abatacept, ustekinumab, rituximab, belimumab, or any other B cell targeted therapies (approved or investigational) within 24 weeks of screening; or any other biologic therapy within 4 weeks of inclusion, whichever is longer.
* 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
* Have evidence of active tuberculosis as documented by medical history, clinical symptoms, and abnormal chest x-ray at screening together with positive quantiferon or T spot test or positive culture
* Have evidence of latent TB (as documented by a positive quantiferon or T spot test, no clinical symptoms consistent with active TB, and a normal chest x-ray at screening, or as outlined below) unless patient completes at least 4 weeks of appropriate treatment prior to inclusion and agrees to complete the remainder of treatment while in the trial.
* Renal impairment with estimated creatinine clearance \< 50 ml/mn (Cockroft and Gault formula)
* Have had any major surgery within 8 weeks prior to screening or will require major
* surgery during the study that, in the opinion of the investigator in consultation with the principal investigator, would pose an unacceptable risk to the patient.
* Past history of lymphoproliferative disease
* Past history of acute myocardial infection or unstable angina
* Past history of stroke (including transient ischemic attack)
* Uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic BP (SBP), or \> 100 mm Hg diastolic BP (DBP) despite optimal antihypertensive treatment
* Past history NYHA (New York Heart Association) class III or IV congestive heart failure
* Thromboembolic event within 6 months before inclusion
* current or past long-time smokers defined by more than 15 pack years
* Second or third atrioventricular block
* Active cancer
* Past history of cancer the 5 years before the inclusion with the following exception:
* -Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study.
* -Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study.
* Have had symptomatic herpes zoster infection within 6 months prior to screening
* Have a past history of recurrent symptomatic zona (one single symptomatic zona that had occurred more than 6 months before the inclusion is not a contra-indication)
* Have a history of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia).
* Have been exposed to a live vaccine within 12 weeks prior to planned inclusion or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination that must occur \> 4 weeks prior to inclusion).
* Have active or chronic viral infection from hepatitis B virus (HBV, defined by positive aghbs), hepatitis C virus (HCV, defined by positive PCR), or human immunodeficiency virus (HIV, defined by positive serology).
* Patients under guardianship (tutelle/curatelle)
* Patient deprived of liberty under judicial or administrative decision.
* Participation in another interventional trial
* Hypersensitivity to the active substance (baricitinib) or to any of the excipients
* Past history of organ transplantation
* Surgery of the target IHCA required at diagnosis validated by a multidisciplinary tumor board during the screening process due to the following reason:
* Male with HCA accessible to liver resection (male not accessible to surgery based on a multidisciplinary tumor board evaluation could be included)
* Activation of the Wnt/B-catenin pathway at immunohistochemistry (diffuse positive glutamine synthase and/or nuclear translation of B-catenin) or mutations in exon 3 of CTNNB1 at molecular biology (except in this tumor is considered as unresectable) at the pathological reviewing
* Signs of malignant transformation in HCC (suspected by multidisciplinary tumor board based on imaging features or results of histology)
* Any other reasons validated by the multidisciplinary tumor board
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jean-Charles NAULT, PUPH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique des Hôpitaux de Paris (APHP)
Locations
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NAULT
Bobigny, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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JEAN CHARLES NAULT, PUPH
Role: primary
References
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Dokmak S, Paradis V, Vilgrain V, Sauvanet A, Farges O, Valla D, Bedossa P, Belghiti J. A single-center surgical experience of 122 patients with single and multiple hepatocellular adenomas. Gastroenterology. 2009 Nov;137(5):1698-705. doi: 10.1053/j.gastro.2009.07.061. Epub 2009 Aug 5.
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Rebouissou S, Amessou M, Couchy G, Poussin K, Imbeaud S, Pilati C, Izard T, Balabaud C, Bioulac-Sage P, Zucman-Rossi J. Frequent in-frame somatic deletions activate gp130 in inflammatory hepatocellular tumours. Nature. 2009 Jan 8;457(7226):200-4. doi: 10.1038/nature07475. Epub 2008 Nov 19.
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Bayard Q, Caruso S, Couchy G, Rebouissou S, Bioulac Sage P, Balabaud C, Paradis V, Sturm N, de Muret A, Guettier C, Bonsang B, Copie C, Letouze E, Calderaro J, Imbeaud S, Nault JC, Zucman-Rossi J. Recurrent chromosomal rearrangements of ROS1, FRK and IL6 activating JAK/STAT pathway in inflammatory hepatocellular adenomas. Gut. 2020 Sep;69(9):1667-1676. doi: 10.1136/gutjnl-2019-319790. Epub 2020 Jan 6.
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Poussin K, Pilati C, Couchy G, Calderaro J, Bioulac-Sage P, Bacq Y, Paradis V, Leteurtre E, Sturm N, Ramos J, Guettier C, Bardier-Dupas A, Boulai A, Wendum D, Selves J, Izard T, Nault JC, Zucman-Rossi J. Biochemical and functional analyses of gp130 mutants unveil JAK1 as a novel therapeutic target in human inflammatory hepatocellular adenoma. Oncoimmunology. 2013 Dec 1;2(12):e27090. doi: 10.4161/onci.27090. Epub 2014 Jan 3.
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Reference Type
BACKGROUND
Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, Germino R, Menon S, Sun Y, Wang C, Shapiro AB, Kanik KS, Connell CA; ORAL Surveillance Investigators. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med. 2022 Jan 27;386(4):316-326. doi: 10.1056/NEJMoa2109927.
Reference Type
BACKGROUND
Gregory J, Dioguardi Burgio M, Corrias G, Vilgrain V, Ronot M. Evaluation of liver tumour response by imaging. JHEP Rep. 2020 Apr 28;2(3):100100. doi: 10.1016/j.jhepr.2020.100100. eCollection 2020 Jun.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP220916
Identifier Type: -
Identifier Source: org_study_id