Study on Baricitinib for Treating Large Inflammatory Liver Adenomas in Women and Non-Resectable Cases in Men

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What is this study about?

This clinical trial is focused on studying a condition known as inflammatory hepatocellular adenoma, which is a type of liver tumor. The study will explore the effects of a treatment using a medication called baricitinib, which is also known by its code names LY-3009104 and INCB-028050. Baricitinib is taken orally in the form of film-coated tablets, available in 2 mg and 4 mg doses. The purpose of the study is to determine if combining baricitinib with standard care, such as stopping estrogen-based contraception and losing weight if necessary, can significantly reduce the size of these liver tumors.

The study will involve participants taking baricitinib daily for a period of up to 26 weeks. Throughout the study, participants will undergo regular imaging tests, such as MRI scans, to monitor changes in the size of the tumors. The goal is to see if the treatment can lead to a decrease in tumor size by at least 30% in a significant number of patients. The study will also track any side effects or adverse events related to the treatment, including the occurrence of conditions like shingles, cancer, or major cardiovascular events.

Participants will be monitored for up to 24 months to assess the long-term effects of the treatment. This includes observing any changes in the tumors after stopping baricitinib and evaluating the need for liver surgery. The study aims to provide valuable insights into the effectiveness of baricitinib in treating inflammatory hepatocellular adenomas and improving patient outcomes.

1 joining the study

Upon joining the study, ensure that all eligibility criteria are met, including a confirmed diagnosis of inflammatory hepatocellular adenoma (HCA) through histology.

Provide written informed consent for participation in the study.

2 initial assessment

Undergo initial imaging to confirm the size and characteristics of the inflammatory HCA.

Ensure that any estrogen-based contraception is discontinued if applicable, and consider weight loss if overweight.

3 treatment initiation

Begin treatment with baricitinib, an oral medication. The dosage is 4 mg per day.

Continue this treatment for a period of 6 months.

4 monitoring and follow-up

Undergo MRI scans at 3 months and 6 months to assess the size of the HCA and any changes according to RECIST 1.1 criteria.

Monitor for any adverse events related to the treatment, including potential side effects such as zona, cancer, or cardiovascular events.

5 treatment evaluation

Evaluate the primary endpoint at 6 months to determine if there is a decrease in the target lesion size of at least 30%.

Assess the overall radiological response, including partial and complete responses, stable disease, and progressive disease.

6 post-treatment follow-up

After discontinuing baricitinib at 6 months, continue follow-up for up to 24 months.

Monitor for any progression of the disease or changes in tumor size during this period.

Who Can Join the Study?

Women or men with a specific type of liver growth called inflammatory HCA. For women, at least one of these growths must be larger than 5 cm.
Must have had a past infection of the Varicella zoster virus (the virus that causes chickenpox) confirmed by a blood test or have been vaccinated against it more than 4 weeks before joining the study.
Must have medical insurance coverage.
Must provide written consent to participate in the study.
Must have a liver growth called hepatocellular adenoma (HCA) confirmed by a special review process.
Must have at least one HCA of the inflammatory subtype confirmed by special tests called histology and immunohistochemistry.
For women, must have at least one HCA larger than 5 cm confirmed by imaging tests.
The liver growth must have been diagnosed within the last 5 years.
Must not want to become pregnant while taking the study medication and for at least 4 weeks after the last dose.
Women who can have children must use a form of birth control that does not contain estrogen while taking the study medication and for at least 4 weeks after the last dose. If using oral birth control, it must have been used for at least one month before starting the treatment.
Men must use birth control when having sexual intercourse with a female partner while taking the study medication and for at least 4 weeks after the last dose.

Who Cannot Join the Study?

Women with an inflammatory HCA (Hepatocellular Adenoma, a type of liver tumor) that has been confirmed through a test called histology, and with at least one tumor larger than 5 cm.
Men with at least one inflammatory HCA confirmed by histology, regardless of the size, if the tumor cannot be removed as decided by a group of medical experts.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Assistance Publique Hopitaux De Paris	Paris	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Assistance Publique Hopitaux De Paris	Paris	France
Hopital Beaujon	Clichy	France
Hospital Paul Brousse	Villejuif	France
Assistance Publique Hopitaux De Paris	Creteil	France
Arhqrmgoql Pvqbzfnm Hwnsljdz Dn Pziqq	Paris	France
Czzpho Hfyzqxzgkhv Uqowhxyhevddr Rcncq	Reims	France
Hcnfihw Hyius Mmwdif &momfsr 1 rdz Gjsfiwg Exrduv	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.09.2024

Trial locations

Investigated drugs:

Baricitinib

Baricitinib is an oral medication used in this trial. It is a JAK1/2 inhibitor, which means it works by blocking certain enzymes in the body that are involved in inflammation. In this study, it is being tested to see if it can help reduce the size of large inflammatory liver tumors known as hepatocellular adenomas.

Estrogen-based contraception discontinuation is part of the standard care in this trial. If patients were using estrogen-based contraceptives, they are asked to stop using them. This is because estrogen can sometimes contribute to the growth of certain types of liver tumors.

Weight loss is another component of the standard care in this trial. Patients who are overweight are encouraged to lose weight. This is because maintaining a healthy weight can help reduce the risk of liver problems and may contribute to the reduction of tumor size.

Inflammatory Hepatocellular Adenoma (HCA) – Inflammatory Hepatocellular Adenoma is a type of benign liver tumor that is characterized by inflammation. It is more common in women and can be associated with the use of estrogen-based contraception. These adenomas can vary in size, and larger ones, particularly those over 5 cm, may pose a risk of complications. In men, these adenomas are considered non-resectable if surgery is not an option. The condition is identified through histological examination, which confirms the inflammatory nature of the adenoma. Over time, these adenomas may change in size, and monitoring is essential to assess any progression or regression.

Trial ID:

2023-505278-13-00

Protocol code:

APHP220916

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Baricitinib for Treating Large Inflammatory Liver Adenomas in Women and Non-Resectable Cases in Men

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?