Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
This study is testing a new combination of two medicines, called durvalumab and tremelimumab, for people with advanced liver cancer that cannot be removed by surgery. This combination treatment is known as STRIDE. It's a Phase 3 study, meaning it's in the later stages of testing to make sure it's safe and works well. The main goal is to find out how safe and effective STRIDE is as a first treatment for this type of liver cancer. Researchers will carefully check how patients respond to the drugs and any side effects they might experience. This research aims to offer a new potential treatment option for patients.
At a glance
What is this study about?
This study is designed to explore a new way to treat liver cancer that has advanced and can't be treated with surgery. The treatment involves two different medicines: durvalumab and tremelimumab. These drugs are a type of immunotherapy, which means they work by helping your body's own immune system fight the cancer.
Doctors are interested in this combination because they hope it could be a more effective first treatment for advanced liver cancer. This study is in 'Phase 3,' which means it's a large, important step in testing new medicines. The information gathered will help doctors understand how well this treatment works and if it's safe for patients.
The main aim is to see if this combination can shrink the cancer, stop it from growing, or help patients live longer, while also watching carefully for any side effects. Finding new and better treatments for advanced liver cancer is very important, and this study is a step in that direction.
Key takeaways
- This study is for advanced liver cancer that can't be surgically removed.
- It tests two new immunotherapy drugs: durvalumab and tremelimumab.
- The goal is to see how safe and effective this new combination treatment is.
- Participation involves screening, treatment, and follow-up periods.
- Your liver health and general well-being are key factors for joining.
Who may be eligible?
To join this study, your doctors need to have confirmed you have advanced liver cancer that cannot be removed by surgery. You shouldn't have had any other drug treatments for your liver cancer yet, though you might have had other local treatments that are no longer suitable.
Your liver health and general well-being will be checked using specific scores (Child-Pugh and WHO/ECOG PS). For example, if your liver is quite healthy (Child-Pugh Class A), you might be able to join even if you're not feeling as well overall. If your liver is a bit more affected (Child-Pugh Class B), your general well-being needs to be good. Also, if you have certain types of blood clots in your liver's main blood vessel, you might still be able to join under specific conditions. You also need to have at least one spot of cancer that doctors can easily measure.
There are also some things that would mean you couldn't join. For instance, if you have other serious health problems, or if you're pregnant or breastfeeding. If you have hepatitis B or C, you'll need to be receiving treatment for it. All participants must be over 18 and weigh more than 30kg. Both men and women of childbearing potential will need to use effective birth control during the study.
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.
- Do I have advanced liver cancer that cannot be surgically removed?
- Have I received any drug treatments for my liver cancer before?
- Do I have at least one measurable spot of cancer?
- Am I generally well enough to take part, based on my doctor's assessment?
- Am I over 18 years old and weigh more than 30kg?
What does participation involve?
If you join this study, it will involve several stages. First, there's a 'screening' period, which usually lasts up to 28 days. During this time, you'll have various tests and checks to make sure the study is right for you. If you qualify, you'll then enter the 'treatment period' where you'll receive the study medicines, durvalumab and tremelimumab, as advised by the doctors.
After you finish the main treatment, there will be two follow-up periods: a 'safety follow-up' to monitor any side effects, and a 'survival follow-up' to keep track of your health over a longer period. Throughout the study, you'll have regular hospital visits for blood tests, scans, and doctor check-ups to see how you're responding to the treatment and to manage any side effects. The exact number of visits and the total length of your participation will be explained by the study team.
Potential risks and benefits
Locations (40)
- Research SiteVerified postcodeLa Jolla, United States
- Research SiteVerified postcodeShreveport, United States
- Research SiteVerified postcodeDetroit, United States
- Research SiteVerified postcodeBobigny, France
- Research SiteVerified postcodeClichy, France
- Research SiteVerified postcodeCréteil, France
- Research SiteVerified postcodeMarseille, France
- Research SiteVerified postcodeRennes, France
- Research SiteVerified postcodeBerlin, Germany
- Research SiteVerified postcodeCologne, Germany
- Research SiteVerified postcodeFrankfurt, Germany
- Research SiteVerified postcodeLübeck, Germany
Common questions
What is advanced unresectable HCC?
This is liver cancer that has grown and spread, making it impossible to remove through surgery. 'Advanced' means it's progressed, and 'unresectable' means surgery isn't an option.
What are durvalumab and tremelimumab?
These are special drugs called immunotherapies. They work by boosting your body's own immune system to help it find and fight cancer cells more effectively.
What is a Phase 3 study?
A Phase 3 study is one of the final steps in testing a new medicine. It involves a larger number of patients and aims to confirm the drug's safety and effectiveness compared to existing treatments or a placebo.
Can I still join if I have hepatitis B or C?
Yes, if you have hepatitis B, you must be receiving treatment for it. If you have hepatitis C, it needs to be confirmed by tests.
What if I decide to leave the study?
You are free to leave the study at any time for any reason. Your decision will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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