Clinical Trials for Hepatic Adenoma
Currently, there is one ongoing clinical trial investigating treatment options for hepatic adenoma, specifically focusing on inflammatory hepatocellular adenoma. This trial is evaluating the effectiveness of baricitinib combined with standard care measures in reducing tumor size in patients with large inflammatory liver adenomas.
Clinical trial locations
Study on Baricitinib for Treating Large Inflammatory Liver Adenomas in Women and Non-Resectable Cases in Men
This trial is investigating a treatment approach for inflammatory hepatocellular adenoma, which is a specific type of benign liver tumor. The study is taking place in France and focuses on testing whether a medication called baricitinib can help shrink these liver growths when combined with standard care measures.
Who can participate:
- Women with at least one inflammatory hepatocellular adenoma larger than 5 cm, confirmed by tissue examination
- Men with at least one inflammatory adenoma of any size that cannot be surgically removed
- Participants must have had chickenpox in the past (confirmed by blood test) or been vaccinated against it at least 4 weeks before joining
- The liver growth must have been diagnosed within the last 5 years
- Participants must have medical insurance coverage and provide written consent
- Women of childbearing age must use non-estrogen birth control during treatment and for 4 weeks after
- Men must use birth control when having intercourse with female partners during treatment and for 4 weeks after
Who cannot participate:
- Women with inflammatory adenomas larger than 5 cm confirmed by tissue examination are excluded from the control group, as they are the primary study population
- Men with tumors that can be removed surgically are not included in this study
What the trial involves:
The main goal of this study is to determine whether baricitinib, taken as a daily tablet (4 mg dose), can significantly reduce the size of inflammatory liver adenomas. Participants will take the medication for 6 months while also following standard care practices, which include stopping estrogen-based birth control pills (if applicable) and losing weight if overweight.
Throughout the 6-month treatment period, participants will undergo regular MRI scans at 3 months and 6 months to measure any changes in tumor size. The study aims to see if at least 30% of patients experience a significant reduction in tumor size (at least 30% decrease). After completing the 6-month treatment, participants will continue to be monitored for up to 24 months to observe long-term effects, including whether tumors stay smaller, grow back, or require surgery.
The investigational medication:
Baricitinib is an oral medication that works by blocking certain enzymes (called JAK1/2) involved in inflammation. It is available in 2 mg and 4 mg tablet forms. In this trial, participants take 4 mg daily. The medication is being tested to see if it can reduce inflammation and shrink the size of inflammatory liver adenomas when combined with lifestyle changes like discontinuing estrogen-based contraception and achieving weight loss.
The study will carefully monitor for any side effects, including potential complications such as shingles, cancer development, or cardiovascular problems, to ensure participant safety throughout the trial period.
Summary
Currently, there is one clinical trial available for patients with hepatic adenoma, specifically targeting the inflammatory subtype of hepatocellular adenoma. This trial is being conducted in France and represents an important research effort to find non-surgical treatment options for patients with large or non-resectable inflammatory liver adenomas.
The study focuses on baricitinib, a JAK inhibitor medication that targets inflammation, combined with standard care measures such as stopping estrogen-based contraception and weight management. This approach is particularly relevant for women with large tumors (over 5 cm) and men whose tumors cannot be surgically removed. The trial’s emphasis on using MRI imaging to track tumor size changes over time reflects a careful, evidence-based approach to evaluating treatment effectiveness.
Patients interested in this trial should discuss with their healthcare providers whether they meet the eligibility criteria and whether participation might be appropriate for their individual situation.