Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are women, or men whose liver adenoma has been determined to be non-removable by surgery regardless of its size
• People who are willing to provide written consent to take part in the study
• People who have a liver adenoma (hepatocellular adenoma) confirmed by tissue testing, with a stored tissue sample available for review
• People who have at least one liver adenoma of the "inflammatory" subtype, confirmed by specialised laboratory testing reviewed by a central team
• Women who have at least one inflammatory-type liver adenoma measuring more than 5 cm as seen on medical imaging
• People whose liver adenoma was diagnosed by tissue testing within the last 5 years
• People who do not wish to become pregnant during treatment and for at least 4 weeks after the last dose of the study drug
• Women who are able to become pregnant and are willing to use non-estrogen-based contraception during treatment and for at least 4 weeks after the last dose of the study drug (if using oral contraception, it must have been started at least one month before treatment begins)
• Men who are willing to use contraception during sexual intercourse with a female partner while on treatment and for at least 4 weeks after the last dose of the study drug
• People who have had a past chickenpox (Varicella zoster) infection confirmed by a blood test, or who have received a chickenpox vaccine more than 4 weeks before joining the trial
• People who have medical insurance coverage

Who may not be able to join:

• People under 18 years old or over 65 years old
• People who are pregnant or currently breastfeeding
• People using estrogen-based contraception at the time of joining
• People receiving state medical aid (AME)
• People who have had a serious viral, bacterial, fungal, or parasitic infection in the 4 weeks before joining (minor infections such as a common cold or simple urinary tract infection are not considered serious)
• People whose heart tracing (ECG) shows abnormalities that the treating doctor considers to pose an unacceptable health risk
• People with a low platelet count in their blood (below 100,000/mm³)
• People with a low level of a type of white blood cell called neutrophils (below 1,200/mm³)
• People with a low level of a type of white blood cell called lymphocytes (below 750/mm³)
• People with anaemia where haemoglobin is below 9 g/dL
• People currently taking certain immune-suppressing medicines such as methotrexate, azathioprine, or mycophenolate (corticosteroids are an exception)
• People who have recently received certain biological or immune-modifying treatments within specified time periods before joining (confirm exact timeframes with the trial site)
• People with significantly elevated liver enzyme levels or bilirubin levels in their blood above specified thresholds
• People with significant liver impairment as defined by a scoring system called Child-Pugh B or C
• People with signs of active tuberculosis (TB), confirmed through medical history, symptoms, chest x-ray, and specific blood or culture tests
• People with latent (inactive) TB, unless they have completed at least 4 weeks of appropriate treatment before joining and agree to finish the remainder during the trial
• People with reduced kidney function where the estimated clearance rate is below 50 ml/min
• People who have had major surgery within 8 weeks before screening, or who are expected to need major surgery during the trial that the treating doctor considers to pose an unacceptable risk
• People with a past history of blood or lymph system cancers (lymphoproliferative disease)
• People with a past history of heart attack or unstable chest pain (angina)
• People with a past history of stroke, including mini-strokes (transient ischemic attacks)
• People with uncontrolled high blood pressure despite being on optimal treatment
• People with a history of severe heart failure (classified as NYHA class III or IV)
• People who have had a blood clot event (such as deep vein thrombosis or pulmonary embolism) within 6 months before joining
• People who are current or past long-term heavy smokers (more than 15 pack-years)
• People with a specific type of heart conduction problem called second or third degree atrioventricular block
• People with active cancer
• People who have had cancer in the 5 years before joining, with limited exceptions for certain fully treated skin cancers or cervical carcinoma in situ with no signs of return for at least 3 years (confirm with trial site)
• People who have had a symptomatic shingles (herpes zoster) episode within 6 months before screening
• People with a history of repeated shingles episodes
• People with a history of severe or widespread shingles, including cases affecting the eyes, the nervous system, or causing long-term nerve pain
• People who have received a live vaccine within 12 weeks before planned entry into the trial, or who are expected to need one during the study (a shingles vaccine given more than 4 weeks before joining is an exception)
• People with active or ongoing hepatitis B, hepatitis C, or HIV infection
• People under legal guardianship
• People who are deprived of liberty by a court or administrative decision
• People currently participating in another interventional clinical trial
• People with a known allergy or sensitivity to the study drug (baricitinib) or any of its ingredients
• People who have had an organ transplant in the past
• People for whom surgery on the target liver adenoma has been recommended by a multidisciplinary medical team during the screening process, including: men whose adenoma is accessible for surgical removal; people whose adenoma shows activation of a specific molecular pathway (Wnt/B-catenin) on laboratory testing, unless the tumour is considered non-removable; people whose imaging or tissue results suggest possible cancerous change; or any other reason determined by the multidisciplinary medical team

Important: Always verify eligibility with the trial site directly before applying.