Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC
This research study, called IMMUWIN, is investigating a new treatment approach for a type of liver cancer known as hepatocellular carcinoma (HCC) that is in an intermediate stage and cannot be removed by an operation or other local treatments. The study is a Phase II trial, which means it's testing the safety and how well a new combination of treatments works. It brings together two immunotherapy medicines, durvalumab and tremelimumab, with a targeted radiation treatment called Y-90 SIRT (Selective Internal Radiation Therapy). Immunotherapy helps your body's own immune system fight cancer, while Y-90 SIRT delivers radiation directly to the tumour. Researchers want to see if this combined approach can be a good option for patients with this specific type of liver cancer.
At a glance
What is this study about?
This study is called IMMUWIN, and it's looking into a new way to treat a type of liver cancer called hepatocellular carcinoma, or HCC. This particular study focuses on people whose liver cancer is in an intermediate stage and can’t be removed by surgery or other local treatments like ablation. It's a Phase II study, which means the researchers are checking if the treatment is safe and if it helps to shrink or control the cancer.
The treatment being tested is a combination of different therapies. It includes two types of immunotherapy medicines, durvalumab and tremelimumab. These drugs help your body's own immune system to recognise and fight cancer cells. Think of it like giving your immune system a boost to do its job better. Alongside these two medicines, the study also uses a treatment called Y-90 SIRT. This is a type of targeted radiation therapy where tiny radioactive beads are delivered directly to the liver tumour to kill cancer cells, while trying to protect the healthy liver tissue.
The main goal of this study is to see how well these three treatments work together. Researchers want to find out if combining immunotherapy with targeted radiation can be a more effective way to treat this specific type of liver cancer. They will be carefully monitoring participants to understand the treatment's effects and any potential side effects.
Key takeaways
- This study tests a new three-part treatment for a specific liver cancer.
- It combines two immune-boosting drugs with targeted radiation.
- Participation involves regular check-ups and monitoring.
- It's for intermediate-stage liver cancer that can't be surgically removed.
- The aim is to find out if this combination is safe and effective.
Who may be eligible?
To join this study, people need to be at least 18 years old and generally well, able to go about their daily activities. They must have been diagnosed with hepatocellular carcinoma (HCC) that has been confirmed by a biopsy. Importantly, their cancer should be in an intermediate stage, meaning it can't be removed by surgery or easily treated with other simple local methods. They also need to be scheduled for local treatment as part of their usual care.
There are also some health requirements. For example, your blood tests for things like blood count, kidney function, and liver function need to be within certain healthy ranges. You also can’t have had other cancer treatments before joining this study. Your liver function, specifically, needs to be adequate, as assessed by a score called Child-Pugh A. If you are female and could become pregnant, you'll need to have a negative pregnancy test and use effective contraception during the study. Men will also need to use contraception if they are sexually active with a partner who could become pregnant.
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 at least 18 years old?
- Do you have a diagnosis of hepatocellular carcinoma (liver cancer) confirmed by a biopsy?
- Is your liver cancer in an intermediate stage and considered not suitable for surgery or simple local treatments?
- Have you not had other cancer drug treatments before?
- Are your general health and blood tests within healthy ranges?
- Are you willing to use contraception if you or your partner could become pregnant?
What does participation involve?
If you decide to take part in this study, you will first have a number of checks to make sure the study is right for you. This will involve blood tests, scans (like CT or MRI), and a general health check. If you meet the criteria, you will receive the study treatments, which include the immunotherapy drugs durvalumab and tremelimumab, and the Y-90 SIRT radiation therapy. The specific schedule for these treatments will be explained to you by the study team. You will have regular appointments for check-ups, blood tests, and scans to monitor how you are doing and how the treatment is working. This will help the doctors keep track of your health and any side effects. The total duration of your participation in the study will depend on how you respond to the treatment and the study's follow-up plan, which the study team will explain in detail.
Potential risks and benefits
Locations (12)
- Universitätsklinikum BonnVerified postcodeBonn, Germany· Recruiting
- Universitätsklinikum KölnVerified postcodeCologne, Germany· Recruiting
- Universitätsklinikum EssenVerified postcodeEssen, Germany· Recruiting
- Universitätsklinikum FreiburgVerified postcodeFreiburg im Breisgau, Germany· Withdrawn
- Universitätsmedizin GöttingenVerified postcodeGöttingen, Germany· Recruiting
- Medizinische Hochschule HannoverVerified postcodeHanover, Germany· Recruiting
- Universitätsklinikum JenaVerified postcodeJena, Germany· Recruiting
- Universtitätsklinikum Schleswig-HolsteinVerified postcodeLübeck, Germany· Recruiting
- Klinikum rechts der Isar der Technischen Universität MünchenVerified postcodeMünchen, Germany· Recruiting
- München Klinik BogenhausenVerified postcodeMünchen, Germany· Recruiting
- Universitätsklinikum MünsterVerified postcodeMünster, Germany· Recruiting
- Universitätsklinikum TübingenVerified postcodeTübingen, Germany· Recruiting
Common questions
What is immunotherapy?
Immunotherapy uses medicines to help your own body's defence system, called the immune system, find and fight cancer cells more effectively.
What is Y-90 SIRT?
Y-90 SIRT is a special radiation treatment where tiny radioactive beads are put directly into your liver to target and kill cancer cells, aiming to spare healthy tissues.
What stage of liver cancer is this study for?
This study is for people with 'intermediate stage' liver cancer (HCC) that cannot be removed by surgery or treated with other local methods.
Will this treatment cure my cancer?
This is a research study to investigate a new treatment combination. While the aim is to improve outcomes, we cannot make claims about cure. The study aims to see how safe and effective it is.
What if I get pregnant during the study?
Female participants must not be pregnant and must use effective contraception. If you think you might be pregnant during the study, you must tell the study team immediately.
How to find out more
Arndt Vogel, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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