Clinical investigation evaluating safety and efficacy of selective intra-arterial 166Holmium radiation therapy in combination with atezolizumab and bevacizumab for non resectable Hepatocellular carcinoma (HOLMBRAVE)
This research study, called HOLMBRAVE, is investigating a new treatment approach for a type of liver cancer that doctors can't remove with surgery. The treatment involves a special kind of radiation therapy, called 166Holmium radiation, delivered directly into the liver. This radiation is combined with two existing medications: atezolizumab (Tecentriq) and bevacizumab (Avastin). Researchers want to find out if this combination is safe and if it can effectively shrink liver tumors. They will be looking at how well the tumors respond after six months using scans and also checking for any side effects. This is a Phase II study, meaning it's an early-stage trial exploring the treatment's effectiveness and safety.
At a glance
What is this study about?
This study, named HOLMBRAVE, is exploring a new way to treat a type of liver cancer called hepatocellular carcinoma (HCC). This particular study focuses on HCC that doctors can't remove with surgery. The main idea is to combine a special type of radiation therapy, applied directly to the liver using a substance called 166Holmium, with two well-known medications: atezolizumab and bevacizumab. Atezolizumab works by boosting your body's immune system to fight cancer, while bevacizumab aims to starve the tumor by blocking the growth of new blood vessels.
The researchers want to see if this combination treatment can make the tumors shrink or disappear. They will be carefully measuring whether the tumors respond well to the treatment, particularly six months after the radiation therapy, using detailed imaging scans like CT or MRI. They will also be closely monitoring any side effects to understand how safe the treatment is. This is a "Phase II" study, which means it's an early-stage trial where scientists are primarily looking at how effective the treatment is and if it’s safe enough to move on to larger studies.
Beyond simply checking if tumors shrink, the study also aims to understand why some treatments work better than others. They will be looking for specific signs in the body (called biomarkers) that might predict if a patient will respond well or experience side effects. They will also be examining how the treatment affects the immune system and blood vessel growth within the tumors and in the blood, to gain a deeper understanding of how these medicines work together.
Key takeaways
- Targets liver cancer (HCC) that cannot be surgically removed.
- Combines liver radiation with two immune-boosting and anti-blood vessel medicines.
- Main aim is to measure if tumors shrink and check for safety.
- This is an early-stage study exploring a new treatment approach.
- Open to adults aged 18 and over, both men and women.
- Regular hospital visits for treatment and monitoring are required.
Who may be eligible?
To be considered for this study, you must be at least 18 years old, and the study is open to both men and women.
The main requirement is that you have hepatocellular carcinoma (liver cancer) that cannot be removed by surgery. There will also be other specific health requirements and medical history checks that the study doctors will go through with you. These checks are important to make sure the treatment is as safe as possible for you and that the study results are clear.
It's important to understand that not everyone with this type of liver cancer will be able to join the study. The study team will review your medical information carefully to see if you meet all the necessary criteria.
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 (liver cancer)?
- Has your doctor told you that your liver cancer cannot be removed by surgery?
- Are you able to travel for regular hospital visits and treatments?
What does participation involve?
If you decide to take part in this study, you will receive a special type of radiation therapy to your liver using 166Holmium, along with regular infusions of two medicines, atezolizumab and bevacizumab. The study involvement will include several hospital visits for the treatments and follow-up checks. You'll have regular scans, such as CT or MRI, to see how your liver cancer is responding to the treatment, particularly at 6 months after the radiation. You will also have blood tests and possibly tumor tissue samples taken to help researchers understand how the treatment works and to check for any side effects. The exact number of visits and the total duration of your participation will depend on how you respond to the treatment and the study schedule, but it involves ongoing monitoring for at least 6 to 12 months.
Potential risks and benefits
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Common questions
What type of cancer is this study for?
This study is for a specific type of liver cancer called hepatocellular carcinoma (HCC) that doctors cannot remove with surgery.
What treatments are involved?
The study combines a special radiation therapy (166Holmium) given directly into the liver with two medicines given by infusion: atezolizumab (Tecentriq) and bevacizumab (Avastin).
What is the main goal of the study?
The main goal is to see if this combination treatment is safe and effective in shrinking liver tumors.
How long will I be involved in the study?
Your involvement will include ongoing monitoring for at least 6 to 12 months, with regular hospital visits for treatment and check-ups.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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