Steroid Sparing in Immune Related Hepatitis (irH)
This study, called 'Steroid Sparing in Immune Related Hepatitis,' is for people who have developed liver inflammation (hepatitis) as a side effect of certain cancer treatments called immune checkpoint inhibitors. These treatments help your body's immune system fight cancer, but can sometimes cause unwanted side effects like liver problems. We are comparing two approaches to treating this liver inflammation: one group will be closely monitored, and steroids (strong anti-inflammatory medicines) will only be given if their condition gets worse. The other group will receive steroids early on. The main goal is to find out if closely watching and giving steroids only when necessary is just as good, or 'non-inferior,' to giving steroids early, but with fewer side effects. We want to understand how to best manage this condition and use steroids wisely.
At a glance
What is this study about?
When you have certain types of cancer, doctors might suggest treatments called 'immune checkpoint inhibitors' (ICIs). These treatments are like giving your immune system a boost to help it find and fight cancer cells. While they can be very effective, sometimes this 'boost' can also make your immune system target healthy parts of your body by mistake. This can lead to side effects, which doctors call 'immune-related adverse events' (irAEs).
One of these possible side effects is inflammation of the liver, called 'immune-related hepatitis' (irH). This doesn't happen to everyone, but it can be serious if not managed properly. The usual treatment for irH is a type of medicine called steroids, which are very good at calming down inflammation. However, taking high doses of steroids for a long time can also cause unwanted side effects.
This study is trying to find the best way to treat irH. We want to see if we can still treat the liver inflammation effectively, but perhaps use fewer steroids or start them later, to avoid some of those side effects. By understanding this better, doctors can make more informed decisions about when and how to give steroids to patients with irH, aiming for the best possible outcome with the fewest problems.
Key takeaways
- This study compares two ways to treat liver inflammation from cancer immunotherapy.
- It aims to reduce steroid use and their side effects if possible.
- Patients will be assigned to either close monitoring or early steroid treatment.
- Regular blood tests will track liver health.
- The study lasts for 12 weeks, with follow-up as needed.
Who may be eligible?
To join this study, you need to be at least 18 years old and capable of understanding and agreeing to take part. You must be receiving a specific type of cancer immunotherapy (called anti-PD1, anti-PDL1, or anti-CTLA-4) for your cancer. Importantly, you would have developed liver inflammation (hepatitis) as a side effect of this treatment, which your doctors believe is due to the immunotherapy and is either a moderate or severe reaction (Grade 2 or 3).
There are also some reasons why you might not be able to join. For example, if you have other types of liver disease that aren't related to your cancer treatment, such as Hepatitis B or C, or if you have severe side effects from your immunotherapy in other parts of your body (like your gut or lungs, but not hormone gland problems that are easily treated). We also need to be sure that any liver problems are because of the immunotherapy and not from other medicines you might be taking.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you currently receiving specific immunotherapy for cancer?
- Have you developed moderate or severe liver inflammation (hepatitis) from your immunotherapy?
- Are your liver problems believed to be from the immunotherapy, not other causes?
- Do you have other serious immunotherapy side effects (apart from easily treated hormone issues)?
What does participation involve?
If you decide to join this study, you would be randomly assigned to one of two groups, like flipping a coin. One group will have their liver closely monitored without starting steroids right away, and steroids will only be given if their liver inflammation gets worse. The other group will start on a higher dose of steroids early on. The study treatment period will last for 12 weeks. During this time, your liver function will be checked by blood tests twice a week. Once your liver inflammation has improved (for example, if a severe reaction becomes moderate, or a moderate reaction becomes mild), these blood tests might be reduced to once a week. If your liver tests remain elevated but you don't have symptoms, your doctors will carefully consider if the monitoring strategy needs to be adjusted.
Potential risks and benefits
Locations (1)
- Arthur J.E. Child Comprehensive Cancer CentreVerified postcodeCalgary, Canada· Recruiting
Common questions
What is 'immune-related hepatitis'?
It's when your liver becomes inflamed as a side effect of certain cancer immunotherapy treatments.
Why are steroids used for this condition?
Steroids are strong medicines that help calm down inflammation in your body, including in your liver.
What does a 'non-inferiority' study mean?
It means the study wants to see if a new treatment approach is at least as good as the standard one, but maybe with fewer downsides.
Will I still get my cancer treatment during the study?
The study focuses on managing the liver side effect, but your overall cancer treatment plan will be discussed by your medical team.
How long will I be in the study?
The main treatment period for the study is 12 weeks, with regular blood tests to check your liver.
How to find out more
Omar F Khan, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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