Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
This important study is looking into new ways to help people with a type of liver cancer called hepatocellular carcinoma. It focuses on patients who have successfully had their cancer treated, for example, by surgery or burning it away, but doctors think there's a good chance it might come back. The study is testing one or two new drugs, durvalumab and bevacizumab, to see if they can stop the cancer from returning. Some people will receive durvalumab alone, some durvalumab plus bevacizumab, and others a dummy treatment called a placebo. The aim is to find out if these drugs are safe and effective in preventing the cancer's return, helping patients stay well for longer. This is a worldwide study, meaning many people in different countries will be taking part.
At a glance
What is this study about?
This study is about a type of liver cancer called hepatocellular carcinoma, often shortened to HCC. If you've had HCC and had treatment to get rid of it, like surgery or a procedure called ablation (where heat is used to destroy cancerous cells), this study might be relevant to you. Sometimes, even after treatment, there's a chance the cancer could come back. This study is for people like you who are at a higher risk of their HCC returning.
The main goal of this study is to see if certain new treatments can help prevent the cancer from coming back. We're testing a drug called durvalumab, either on its own or together with another drug called bevacizumab. To understand if these drugs are truly effective, some participants will receive these active drugs, while others will receive a 'placebo', which looks like the study drug but doesn't contain any active medicine. This comparison helps us work out if any changes are truly due to the study drugs.
This is a 'Phase III' study, which means it's one of the final stages of testing before a new treatment might become widely available. Doctors around the world are carefully monitoring participants to see if the study drugs are safe and if they help people stay cancer-free for longer. By taking part, you could be helping to find better ways to treat HCC and prevent it from returning for future patients.
Key takeaways
- This study is for people with liver cancer (HCC) who have had treatment but are at high risk of the cancer returning.
- It's testing two drugs, durvalumab and bevacizumab, alone or in combination, against a dummy treatment (placebo).
- The goal is to see if these drugs can stop the cancer from coming back.
- It's a global, 'Phase III' study, which is a key stage in testing new treatments.
- Your health would be carefully monitored throughout the study.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to have been recently diagnosed with hepatocellular carcinoma (HCC) and have successfully had your cancer removed, either through surgery or a procedure called ablation. Doctors would need to confirm that there's no cancer visible on your scans shortly before you start. Your general health, including how well your liver and other organs are working, would also be checked carefully. You would need to be well enough to carry out most of your daily activities without much difficulty.
There are also some reasons why you might not be able to join. For example, if you have certain rare types of liver cancer, or if scans show the cancer has already spread to other parts of your body. If you've had a problem with your brain due to liver disease in the last year, or if you have specific types of blood clots in your liver's blood vessels, this study wouldn't be suitable. Also, anyone waiting for a liver transplant or who has already received certain types of cancer treatment for HCC would not be able to take part.
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.
- Have you been diagnosed with hepatocellular carcinoma (HCC)?
- Has your HCC been successfully removed by surgery or another procedure?
- Are you generally well and able to manage most daily activities?
- Have recent scans shown no signs of cancer spreading?
- Do you have good overall liver and organ function?
- Are you at least 18 years old?
What does participation involve?
If you decide to take part in this study, you would be assigned to one of three groups by chance, like flipping a coin. You wouldn't know which group you're in, and neither would your doctors, to ensure fair results. One group would receive durvalumab plus bevacizumab, another would receive durvalumab alone, and the third group would receive a placebo (dummy treatment).
Taking part would involve regular visits to the hospital for treatment and check-ups. During these visits, you'd have physical examinations, blood tests, and scans (like CT or MRI) to monitor your health and see how the treatment is working. The study drugs would likely be given as an infusion into a vein, usually at the hospital. You would also be asked about any side effects you experience. The total duration of your active treatment would be determined by the study design, and after that, you would have follow-up appointments to track your long-term health. The exact schedule of visits and tests would be fully explained to you before you agree to join.
Potential risks and benefits
Locations (217)
- Research SiteVerified postcodeBirmingham, United States
- Research SiteVerified postcodeMobile, United States
- Research SiteVerified postcodePhoenix, United States
- Research SiteVerified postcodeCosta Mesa, United States
- Research SiteVerified postcodeLa Jolla, United States
- Research SiteVerified postcodeLong Beach, United States
- Research SiteVerified postcodeOrange, United States
- Research SiteVerified postcodeSacramento, United States
- Research SiteVerified postcodeWashington D.C., United States
- Research SiteVerified postcodeMiami, United States
- Research SiteVerified postcodeTampa, United States
- Research SiteVerified postcodeHonolulu, United States
Common questions
What is hepatocellular carcinoma (HCC)?
HCC is the most common type of primary liver cancer, which means it starts in the liver.
What does 'high risk of recurrence' mean?
It means that after your cancer has been successfully removed, doctors believe there's a higher chance it could come back, based on your specific situation.
What is a placebo?
A placebo is a dummy treatment that looks just like the real drug but contains no active medicine. It helps researchers understand if the study drug is truly having an effect.
Will I know if I'm getting the actual drugs or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over or in specific medical situations.
What happens if I decide I don't want to continue with the study?
You can leave the study at any time, and you don't have to give a reason. Your decision won't affect the care you receive from your doctors.
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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