Perioperative Therapy with Durvalumab Plus Tremelimumab for Patients with Resectable Hepatocellular Carcinoma (HCC) - A Phase II Trial (NEOTOMA)
This clinical trial, called NEOTOMA, is looking into new ways to treat a type of liver cancer that can be removed by surgery. It's a Phase II study, which means we're still in the earlier stages of testing. Patients will receive two medicines, durvalumab and tremelimumab, before their operation. The main goal is to find out how many patients experience side effects that are serious or lead to them stopping treatment. We also want to understand if these medicines cause delays to surgery or make the tumour shrink. Researchers will also be looking closely at how the body's immune system responds to these treatments to learn more about how they work against cancer.
At a glance
What is this study about?
This study is for people in the UK who have a type of liver cancer called hepatocellular carcinoma (HCC) that doctors believe can be removed with an operation. It's called NEOTOMA and is a Phase II clinical trial. This means it's an important step in researching new treatments, focusing on whether a treatment is safe and if it shows early signs of being effective.
The main idea behind this study is to give two particular medicines, called durvalumab and tremelimumab, to patients before their surgery. These medicines are types of immunotherapy, which means they work by helping your body's own immune system fight cancer. The researchers want to see if this approach can improve treatment for liver cancer.
Key things the study will be looking at include any side effects patients experience and whether these side effects are serious enough to stop treatment or delay surgery. They will also measure if the treatment makes the tumour smaller and how much cancer is left after surgery. By collecting these details and doing extra tests on blood and tissue, doctors hope to understand better how these medicines work and who might benefit most from them in the future.
Key takeaways
- This is a Phase II study for a type of liver cancer that can be operated on.
- It tests two new immunotherapy medicines, durvalumab and tremelimumab, given before surgery.
- The main focus is on monitoring safety and side effects, and seeing how well the treatment works.
- The study aims to improve understanding of how these medicines fight cancer.
- Participation involves receiving medicines, regular checks, and follow-up after surgery.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. Both men and women can take part.
You must have been diagnosed with hepatocellular carcinoma (HCC), which is a specific type of liver cancer. Importantly, doctors must believe that your cancer can be removed with an operation.
There will also be other specific medical checks and tests to make sure that the treatment is safe for you and that you meet all the study's requirements. Your doctor will be able to tell you if you might be suitable.
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?
- Do you have hepatocellular carcinoma (HCC), a type of liver cancer?
- Has your doctor told you that your liver cancer can be removed with an operation?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part, you will receive two medicines, durvalumab and tremelimumab, before your scheduled surgery. These will likely be given as infusions (into a vein) at a hospital or clinic, over a period of time. You will have regular appointments and tests, including blood tests and scans, to check how you are responding to the treatment and to monitor for any side effects.
The main part of the study involves receiving these medicines before your operation, which will happen as planned after the pre-operative treatment. After your surgery, the research team will continue to follow your health. They will keep in touch to understand how you are recovering and how you are doing in the long term. The total duration of your involvement will depend on the study's plan for follow-up after your surgery.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for a specific type of liver cancer called hepatocellular carcinoma (HCC) that can be removed with surgery.
What medicines are being tested?
Two medicines called durvalumab and tremelimumab are being tested in this study.
Why are these medicines given before surgery?
The study aims to see if giving these medicines before surgery can improve the treatment outcome and how the immune system responds to the cancer.
What does Phase II mean?
Phase II means this is an earlier stage of research, where doctors are mainly looking at the safety of the treatment and if it shows promising early signs of working.
Will I still have my surgery if I join this study?
Yes, if you join, you will still have your surgery as planned after receiving the study medicines, unless serious side effects prevent it.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.