Not yet recruiting

A study to evaluate the safety and effectiveness of oxaliplatin delivered directly to the liver for patients with colorectal cancer and liver metastasis

Registered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates a new way to treat colorectal cancer, which is a type of cancer that starts in the large intestine or rectum. Specifically, the research focuses on patients who have liver metastasis, meaning the cancer has spread from the original site to the liver. The treatment being studied is a method called Liver Isolated Oxaliplatin, or LIOX, which involves using the drug oxaliplatin to target the cancer cells directly in the liver.

The purpose of the study is to determine if this specific method of delivering medication is safe and practical for patients. During the study, the oxaliplatin is administered through an infusion, which is a process where medicine is delivered into the bloodstream through a tube. This delivery is done using an arterial access device, a small tool placed into an artery to allow medicine to be sent directly to the liver area.

The research process

The trial runs in 1 step.

Step 1
Administration of oxaliplatin
The oxaliplatin medication is administered through an infusion, which is a method where medicine is delivered directly into the bloodstream through a tube.
The dosage is 50 mg/m2, which means the amount of medicine is calculated based on the body surface area.
The medicine is delivered via an arterial access device, which is a small tool placed in an artery to allow medicine to reach the liver directly.

Who can join the trial?

11 criteria

You must give your voluntary written informed consent, which means you or your legal representative agrees to take part in the study by signing a document before any tests begin.
You must be at least 18 years old when you sign the agreement.
You must use highly effective birth control, such as implants, certain pills, or other methods that have a very low chance of failure, to prevent pregnancy during the study.
Women who are pre-menopausal (meaning they have had a period within the last 12 months) must be willing to use medication to stop their menstrual cycle during treatment.
You must have hepatic metastases, which means cancer cells that have spread to the liver, originating from a proven type of cancer called adenocarcinoma in the colon or rectum.
You must have previously received certain types of chemotherapy or targeted drugs, including 5-FU, oxaliplatin, irinotecan, bevacizumab, or EGFR inhibitors.
You must have measurable liver lesions, which are tumors in the liver that can be clearly seen and measured on medical scans, and these must be located only in the liver or in very limited areas outside the liver.
The original tumor must have been resected, meaning it was surgically removed.
You must have an ECOG performance status of 0-1, which is a scale used by doctors to describe how well a patient can perform daily activities; a score of 0 or 1 means you are fully active or able to do light work.
You must be considered healthy enough by a doctor to undergo general anesthesia, which is a medicine used to make you sleep deeply during a medical procedure.
The inner diameter of the specific peripheral artery (an artery located away from the heart) that the doctors plan to use must be 6mm or larger.

Who cannot join the trial?

14 criteria

A history of allergies to contrast agents, which are special dyes used during medical imaging tests.
A history of hypersensitivity or laryngo-pharyngeal dysaesthesia, which refers to unusual or uncomfortable sensations in the throat and voice box, specifically related to the medication oxaliplatin.
A history of any allergic reactions related to the medication oxaliplatin.
Inadequate liver function, meaning the liver is not working correctly, specifically if levels of bilirubin (a yellow substance in the blood) or AST (a type of liver enzyme) are too high.
Abnormal blood clotting, which is measured by the INR (a test that shows how long it takes your blood to clot), if the value is higher than 1.5.
Having medical conditions that make it impossible or unsafe to perform the required tests for this study.
Having peripheral neuropathy of a moderate to severe level, which is nerve damage that causes numbness, tingling, or pain in the hands and feet.
Having received treatment with monoclonal antibodies, which are types of medicines made in a lab to target specific parts of the immune system, within 4 weeks before the device is put in place.
Being pregnant, breastfeeding, planning to become pregnant, or being able to become pregnant without using a highly effective form of contraception (birth control).
Currently participating in another clinical trial involving a new medicine or a new medical device.
Having other significant co-morbidities, which means having other serious health problems alongside the main condition being studied.
Having a life expectancy of less than 3 months.
Inadequate bone marrow function, meaning the part of the body that produces blood cells is not working correctly, specifically if levels of haemoglobin (protein that carries oxygen), ANC (a type of white blood cell), or platelets (cells that help blood clot) are too low.
Inadequate renal function, which means the kidneys are not filtering the blood properly, specifically if the level of serum creatinine (a waste product measured in the blood) is too high.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Oxaliplatin is a type of chemotherapy medication used to treat cancer. In this study, it is delivered directly into the liver to target cancer that has spread from the colon to the liver.

Oxaliplatin

What is already known about the treatment

Oxaliplatin - This medication is an anticancer drug that is administered through an IV drip, specifically into an artery in this study, to target cancer cells directly. It is a well-established treatment used primarily to manage certain types of cancer, including colorectal cancer. At a molecular level, it works by binding to the DNA inside cancer cells, which damages their genetic structure and prevents them from multiplying. It is classified as a platinum-based chemotherapy agent.

Investigated diseases

Colorectal cancer - This is a type of disease that starts in the colon or the rectum. It typically begins with the growth of small, noncancerous clumps of cells called polyps on the inner lining of the digestive tract. Over time, some of these polyps can transform into malignant cells. As the disease progresses, these cells grow uncontrollably and can invade nearby tissues. It may also spread to other parts of the body through the blood or lymphatic system.