AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase 2, single arm, open label, study on the safety and feasibility of Liver Isolated Oxaliplatin (LIOX) delivered via arterial access device for treatment of liver metastasis in colorectal cancer patients

This research study is for people with colorectal cancer that has spread to their liver. It's testing a special way to give a chemotherapy drug called oxaliplatin. Instead of going through your whole body, the drug is delivered directly to your liver through a small tube. Doctors want to see if this method is safe and if it helps control the cancer in the liver. This is a "Phase 2" study, which means it's still in the earlier stages. It's called "single arm" because everyone in the study will receive the same treatment. The main goal is to check for any side effects and how many people experience them.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

UZ Leuven

Enrolment target

Start

27 Feb 2026

colorectal cancer

What is this study about?

This study is called a clinical trial, and it's a way for doctors to test new treatments to see if they are safe and if they work. This particular trial is looking at a new way to treat colorectal cancer (bowel cancer) when it has spread to the liver. When cancer spreads, it's called metastasis. The treatment being tested is a chemotherapy drug, which is a medicine used to kill cancer cells, called oxaliplatin.

What makes this study different is how the oxaliplatin is given. Instead of giving the chemotherapy through a drip in your arm, which means it travels throughout your whole body, this study delivers the drug directly to your liver. This is done through a special device, like a small tube, placed into an artery that goes to your liver. The idea is that by concentrating the medicine in the liver, where the cancer is, it might be more effective and cause fewer side effects elsewhere in the body.

This is a 'Phase 2' study, which means it's an earlier stage of research. The main focus at this stage is to check how safe this method is and to see what side effects people might experience. They'll also be looking to see if it helps to control the cancer in the liver. It's an "open label" study, which means both you and your doctors will know you are receiving this specific treatment. Your safety and well-being will be carefully monitored throughout the study.

Key takeaways

This study explores a new way to deliver chemotherapy directly to liver tumours.
It aims to see if this method is safe and helps control colorectal cancer spread to the liver.
The drug used is oxaliplatin, a common chemotherapy medicine.
It's a Phase 2 study, focusing on safety and initial effectiveness.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.

Crucially, you must have colorectal cancer that has spread to your liver. The doctors will also check other things about your health to make sure this treatment is suitable and safe for you. They will look at your overall health, how well your liver and other organs are working, and any other medical conditions you might have.

Not everyone with colorectal cancer that has spread to the liver will be able to take part. The study has specific rules to ensure everyone involved is as similar as possible, which helps doctors understand the treatment's effects clearly. Your doctor will be able to tell you if you meet all the necessary requirements.

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?
Have you been diagnosed with colorectal cancer that has spread to your liver?
Are you able to travel to a study site for regular hospital visits?
Are you generally well enough to undergo cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the oxaliplatin chemotherapy directly into your liver. This process is usually done through a special device placed in an artery that leads to your liver. You would have regular hospital visits for the chemotherapy sessions and for check-ups.

During these visits, doctors and nurses will perform various assessments. This might include blood tests, scans (like CT or MRI scans) to see how the cancer is responding, and general health checks. They will also ask you about any side effects you might be experiencing. The exact number of visits and the full duration of the treatment and follow-up will be explained by the study team, but typically, you would be monitored for a period after your main treatment to see the long-term effects.

Potential risks and benefits

Every medical treatment carries potential benefits and risks, and this study is no different. A potential benefit of this study is that delivering oxaliplatin directly to the liver might reduce cancer in the liver and potentially lead to fewer side effects in other parts of your body compared to standard chemotherapy. However, this is still being investigated. Potential risks could include side effects from the oxaliplatin, which can vary widely, and risks associated with the procedure to insert the delivery device. Your doctor will discuss all known and potential side effects in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is 'colorectal cancer'?

Colorectal cancer is a type of cancer that starts in the large bowel (colon or rectum).

What does a 'Phase 2' study mean?

A Phase 2 study is an earlier stage of research to see if a new treatment is safe and if it shows promise in treating the disease. Doctors will mostly be looking at side effects.

What is oxaliplatin?

Oxaliplatin is a chemotherapy drug, which is a medicine designed to kill cancer cells.

How is the treatment different from regular chemotherapy?

Instead of the drug travelling through your whole body, this study delivers the chemotherapy directly into your liver, where the cancer is located.

Will I know if I'm getting the treatment?

Yes, this is an 'open-label' study, meaning you and your doctors will know you are receiving this specific treatment.