RecruitingOBSERVATIONAL

Checkpoint Inhibitor-induced Liver Injury

This study aims to understand a specific type of liver damage called 'checkpoint inhibitor-induced liver injury' (ChILI), which can occur in some people treated with certain cancer medications known as checkpoint inhibitors. Unlike other types of drug-related liver problems, ChILI is not fully understood. Researchers want to find out how often it happens, what makes someone more likely to develop it, and what signs it shows in the body. They will collect blood and tissue samples from patients who have developed ChILI, as well as from cancer patients starting checkpoint inhibitor treatment. By comparing these groups, they hope to identify key differences and eventually develop better ways to predict and prevent ChILI.

At a glance

Status

Recruiting

Sponsor

University of Nottingham

Enrolment target

160

Start

13 Oct 2020

Estimated completion

30 Jun 2026

Immune-Mediated Hepatitis

What is this study about?

This research is looking into a specific kind of liver problem that can happen to people undergoing treatment for cancer with a type of medicine called 'checkpoint inhibitors'. While these drugs are very effective at fighting cancer, sometimes they can cause the immune system to overreact and accidentally damage healthy organs, including the liver. This specific liver damage is being called 'checkpoint inhibitor-induced liver injury', or ChILI.

The scientists want to understand ChILI much better because it's a relatively new condition and isn't fully understood. They need to find out why some people develop it and others don't, what specific signs in the body might predict it, and how it differs from other types of liver damage caused by medicines. By gathering lots of detailed information from people who have ChILI and those who are starting checkpoint inhibitor treatment, they hope to unlock these mysteries.

The ultimate goal of this study is to develop better 'early warning' systems and improved ways to manage ChILI. This would mean doctors could potentially predict who might be at higher risk before treatment, monitor patients more effectively, and even find ways to prevent this liver damage from happening, making cancer treatments safer for more people.

Key takeaways

Researchers are studying a new type of liver injury from cancer drugs.
The study aims to understand why some people get ChILI and how to spot it early.
Participation involves providing biological samples like blood.
You will not be given new medications as part of the study.
Your standard cancer treatment will continue as normal.
Your involvement helps improve future cancer care.

Who may be eligible?

To join this study, you must be at least 18 years old. The researchers are looking for two main groups of people. One group includes patients who have already developed checkpoint inhibitor-induced liver injury (ChILI). For these patients, there are specific levels of liver enzymes (chemicals in your blood that show how your liver is working) they will look for to confirm the liver injury, and importantly, doctors must have ruled out other common causes for liver damage.

The second group includes cancer patients who are about to start treatment with checkpoint inhibitors. It's expected that a small number of these patients might develop ChILI during their treatment, and if they do, they would then become part of the first group for the purposes of the study.

You would not be able to join if you are receiving other types of chemotherapy at the same time as checkpoint inhibitors, or if the main study doctor believes there's another clear reason for any liver problems you might have.

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?
Have you been diagnosed with a specific type of liver injury potentially linked to checkpoint inhibitors?
Are you a cancer patient who is about to start treatment with checkpoint inhibitors?
Are you *not* currently receiving other chemotherapy alongside checkpoint inhibitors?
Has your doctor confirmed there isn't another clear reason for your liver problems (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves collecting biological samples, such as blood, at different points in time. The exact number and timing of visits would depend on whether you are in the group that has developed ChILI or the group starting checkpoint inhibitor treatment. For those with ChILI, samples would be taken to understand the injury. For those starting treatment, samples would be collected before treatment and at later stages. The study is observational, meaning you would not be given new medicines as part of the research; you would continue with your standard cancer treatment as decided by your doctors. The total duration of your participation would depend on your specific situation and the study's monitoring schedule.

Potential risks and benefits

Participating in this study might not offer direct medical benefits to you personally, as it's primarily designed to gather information to help future patients. However, your involvement is crucial for advancing our understanding of ChILI, which could lead to safer cancer treatments for others. Potential risks are generally low, mainly related to blood draws, including minor discomfort, bruising, or rarely, infection. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Nottingham
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What are 'checkpoint inhibitors'?

Checkpoint inhibitors are a type of cancer medicine that helps your body's own immune system fight cancer cells more effectively.

What is 'ChILI'?

ChILI stands for 'checkpoint inhibitor-induced liver injury'. It's a specific type of liver damage that can sometimes happen when people are treated with checkpoint inhibitors.

Will I receive new medicine in this study?

No, this study is observational. You will continue to receive your standard cancer treatment as prescribed by your doctors. The study only involves collecting samples and information.

Will taking part benefit me directly?

While it might not directly improve your health, your participation is vital for helping researchers understand ChILI better, which could lead to improved care for future patients.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Guruprasad Padur Aithal, MBBS, FRCP, PhD

guru.aithal@nottingham.ac.uk 0115 823 1074 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.