Extended Criteria Treatment for Liver Metastases With Heavy Tumour Burden
When bowel cancer spreads to the liver, it can cause numerous secondary tumours that standard surgery cannot easily remove. This study explores an intensive treatment approach for people facing this challenge. Participants receive a combination of medicines, including a chemotherapy drug called floxuridine, a steroid named dexamethasone to reduce irritation, and heparin to keep blood flowing smoothly. These treatments are often delivered directly into the liver's blood supply to target tumours while sparing the rest of the body. The main goal is to measure how many people survive for at least two years after starting treatment. Doctors will also track whether the therapy shrinks tumours enough to make surgery or a liver transplant possible, how long it keeps the cancer from growing, and how it affects everyday quality of life.
At a glance
What is this study about?
Bowel cancer is one of the most common cancers in the UK. In some cases, cancer cells travel from the bowel to the liver, forming secondary tumours known as liver metastases. When there are many tumours scattered throughout the liver, standard surgery to cut them out may not be an immediate option. This trial explores whether a targeted, direct approach can help patients with this heavy tumour burden.
The trial tests a method that delivers cancer-fighting medicines straight into the liver through its main blood supply. By focusing the chemotherapy drug floxuridine directly on the liver, doctors hope to attack the tumours with higher doses while causing fewer body-wide side effects. They also use dexamethasone, a steroid medicine to protect the liver from swelling, and heparin, a blood thinner that prevents blockages in the treatment line.
This is a Phase 2 trial, which means researchers are checking both how well the treatment works and how safe it is. They want to see if this approach can shrink tumours enough to make future surgery or even a liver transplant possible. Most importantly, the study tracks whether people live longer, better lives as a result of this care.
Key takeaways
- Tests a targeted treatment for bowel cancer that has spread heavily to the liver.
- Uses a combination of floxuridine chemotherapy, dexamethasone, and heparin.
- Aims to improve survival rates and see if tumours can be shrunk enough for surgery.
- Open to adults aged 18 and older with suitable general health and liver function.
- Participation is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with bowel cancer that has spread heavily to the liver. Both men and women can take part.
To join, participants usually need to have liver tumours that cannot be removed safely by standard surgery at the start of the study. A person's liver must still be working well enough to process the trial medicines safely.
People who have serious medical conditions unrelated to cancer, severe heart problems, or whose liver is not functioning well enough might not be able to join. Your hospital doctor or oncologist will run blood tests and scans to check if this trial is safe and appropriate for you.
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.
- I am aged 18 or older.
- I have bowel (colorectal) cancer that has spread to my liver.
- My liver tumours cannot currently be removed with standard surgery.
- My liver and kidneys are working well enough for treatment.
- I am well enough to attend regular hospital visits for scans and tests.
What does participation involve?
Taking part involves having a specialised device or line placed to deliver medicines directly to your liver. You will receive regular treatment cycles featuring the chemotherapy drug floxuridine alongside supportive medicines like dexamethasone and heparin. Treatment sessions will take place at the hospital under close medical supervision.
You will need regular hospital visits for health checks, blood tests, and imaging scans (such as CT or MRI scans) to see how well the tumours are responding. Doctors will also ask you to fill in simple questionnaires about your daily wellbeing and quality of life. The active treatment can last several months, and the team will follow your progress for up to two to five years to monitor your long-term health.
Potential risks and benefits
Locations (1)
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Common questions
What is the main goal of this trial?
The main goal is to see if direct liver treatment helps people with extensive bowel cancer spread live for two years or longer, while maintaining a good quality of life.
How is the medicine given?
The medicines are usually delivered directly into the main blood vessel feeding the liver using a small pump or tube, allowing high doses to reach the tumours directly.
Could this treatment make me eligible for surgery?
Researchers are hoping that shrinking the tumours might allow some people to have surgery or a liver transplant later on, though this cannot be guaranteed.
Do I have to pay to take part?
No, clinical trials in the UK do not charge participants for trial medicines or study tests. Some trials may also help cover travel expenses.
What happens if I want to stop the trial?
You can leave the trial at any time without giving a reason. Your doctors will discuss other standard treatment options with you, and your ongoing care will not suffer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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