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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Combining drug-eluting bead chemoembolization and radioembolization for treatment of colorectal liver metastases: DEBIR90Y study

This research study is for people who have bowel (colorectal) cancer that has spread to their liver. Doctors are trying out a new way to treat this by combining two treatments that are already used separately. These treatments deliver medicine or radiation directly to the liver metastases (cancer spots). This is a very early-stage study, called a Phase I, which means the main goal is to check if this combined treatment is safe for patients and to understand how it works in the body. It's hoped that by combining these treatments, it might be more effective in shrinking or controlling the cancer spread in the liver. Finding new and better ways to treat cancer is very important.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Universitair Medisch Centrum Utrecht
Enrolment target
15
Start
22 Aug 2024

What is this study about?

This research study is looking into a new way to treat bowel (colorectal) cancer that has spread to the liver. When cancer spreads from its original place, like the bowel, to another organ like the liver, these new spots are called metastases.

The study is combining two types of treatments that are already known, but usually used separately, to see if they work better together. One treatment is called chemoembolization, which involves delivering powerful cancer-fighting drugs directly to the tumour in the liver, while also blocking its blood supply. The other treatment is called radioembolization, which uses tiny radioactive beads delivered directly to the liver tumours to kill cancer cells with radiation.

This is a 'Phase I' study. This means it's one of the first times this specific combination of treatments is being tested in people. The main aims are to find out if it's a safe treatment, what doses can be given, and to see if there are any side effects. Researchers will also be looking closely at how the body reacts to these treatments and gathering early information on whether the combination might shrink the cancer. This kind of research is crucial for developing better treatments for cancer in the future.

Key takeaways

  • This study is for bowel cancer that has spread to the liver.
  • It combines two special liver treatments: chemoembolization and radioembolization.
  • The main goal is to check if this new combination is safe and works.
  • It's an early-stage (Phase I) study.
  • Both men and women aged 18 and over can be considered.
  • Findings from this study could help develop better cancer treatments.

Who may be eligible?

To join this study, you would need to be at least 18 years old. Both men and women can take part.

The main requirement is that you have bowel (colorectal) cancer that has spread to your liver. The doctors will carefully check your medical history and do some tests to make sure that these specific treatments are suitable for your type of cancer and your overall health.

There might be other health conditions or treatments you are currently receiving that mean you couldn't join. For example, if your liver function isn't strong enough or if you have certain other serious health problems. The study team will discuss all these details with you thoroughly.

Quick self-check
  • Are you 18 years old or older?
  • Have you been diagnosed with bowel (colorectal) cancer?
  • Has your cancer spread to your liver?
  • Are you able to travel to study appointments?
  • Are you willing to undergo specific liver treatments?
  • Are you comfortable with regular medical checks and scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests and scans to check your health and assess your cancer spreading to the liver. This would include blood tests, imaging scans (like MRI or CT), and possibly other procedures.

During the treatment phase, you would receive the combined chemoembolization and radioembolization procedures. These are hospital-based treatments. You would have regular check-ups, blood tests, and scans to monitor how you are responding to the treatment and to keep an eye on any side effects. This might involve several hospital visits over a period.

The study involves follow-up appointments over a longer period to see how you are doing in the months and possibly years after treatment. The exact number and frequency of visits would be explained in full detail by the study team, but generally, research studies require more frequent monitoring than standard care for safety reasons.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. You might benefit from receiving a new combination of treatments that could be more effective for your cancer than standard care, though this is not guaranteed as it's an early-stage study. However, there are potential risks, including side effects from the chemotherapy drugs or radiation, or risks related to the procedures themselves, such as infection or bleeding. The study team will explain all known side effects and risks to you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

  • Netherlands

Common questions

What is chemoembolization?

It's a treatment that puts cancer-fighting drugs directly into the liver tumours and also blocks their blood supply.

What is radioembolization?

This treatment uses tiny radioactive beads delivered to the liver tumours to kill cancer cells with radiation.

Why combine these two treatments?

Doctors are hoping that using both treatments together might be more effective in fighting the cancer in the liver.

Is this a new treatment?

The individual treatments are known, but this study is testing them in a new combination for the first time in people.

What is a 'Phase I' study?

It's an early-stage study focused on checking if a new treatment or combination is safe for patients and how it works.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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