RecruitingNAINTERVENTIONAL

Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases

This study is for people with bowel cancer that has spread only to their liver, and where this spread cannot be removed by traditional surgery. Researchers want to see if a liver transplant from a living donor can help these patients. The study will carefully select participants whose liver tumours are stable and not growing. They'll also need a healthy, willing living donor. Those who receive a transplant will be followed for five years to see how long they live, how long they stay free of cancer, and how their quality of life changes. This will be compared to a group who almost got a transplant but couldn't for reasons other than their cancer worsening, to understand the true benefits of the transplant itself. The goal is to improve survival and quality of life for these patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

03 Aug 2016

Estimated completion

01 Dec 2030

Colorectal Cancer Liver Metastases

What is this study about?

If you have bowel cancer, sometimes it can spread to other parts of your body, most commonly to the liver. When this happens, it's called liver metastases. Normally, if these tumours can be surgically removed from the liver, it can offer a good chance of long-term survival. However, for many people, these liver tumours are too widespread or in a difficult location to be taken out safely. In these cases, unfortunately, the outlook is not as good.

This study is exploring a new approach for a very specific group of these patients: those whose bowel cancer has spread only to their liver, and where these liver tumours cannot be removed by surgery. The idea is to try a complete liver transplant, where the entire diseased liver is replaced with a healthy liver portion from a living donor. This is a very big step, as usually, a liver transplant isn't considered an option for cancer that has spread from another part of the body.

The researchers believe that by being very careful about who receives a transplant – focusing on patients whose liver tumours are stable and not growing after chemotherapy – they can achieve better results than previous studies. They are specifically looking at live donor liver transplants because it means they can plan the timing of the surgery more precisely and ensure the patient is in the best possible health. The aim is to see if this type of transplant can help people live longer, stay free of cancer for longer, and maintain a good quality of life for at least five years.

Key takeaways

This study is testing liver transplants for advanced bowel cancer in the liver.
It's for specific patients whose liver tumours cannot be removed by surgery and are stable on chemotherapy.
A willing, healthy living donor is essential for participation.
The study aims to improve survival and quality of life.
Participants will be followed for five years after transplant.

Who may be eligible?

To be considered for this study, you must be between 18 and 68 years old and live in Canada. Your bowel cancer must have spread only to your liver, and these liver tumours must not be treatable with standard surgery. Very importantly, your liver tumours must also have been stable or shrinking for at least the past three months while you've been having chemotherapy. Your general health also needs to be excellent, meaning you're active and can carry out most daily tasks without difficulty. You must also have a healthy, willing person who is a good match and is prepared to donate a part of their liver to you.

There are also specific medical conditions that would prevent you from taking part. For example, if you've had another type of cancer, or if you have serious heart, lung, or kidney problems. You also cannot participate if your liver tumours are actively growing or have spread outside the liver before the transplant, or if you have specific genetic changes in your tumour called BRAF+. Your doctors will do many tests to check all these details carefully.

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 live in Canada.
I am between 18 and 68 years old.
My bowel cancer has only spread to my liver, and these tumours cannot be treated with surgery.
My liver tumours have been stable or shrinking with chemotherapy for at least the last 3 months.
I am in very good general health and can do most daily activities easily.
I have a healthy family member or friend who might be able to donate part of their liver.

Answer every question to see your result.

What does participation involve?

If you are eligible and decide to take part, you will first undergo a thorough assessment to check both your health and the suitability of your potential living donor. This will involve many tests and appointments. If you proceed to a live donor liver transplant, you will have major surgery. After the transplant, you will have regular check-ups and tests for five years to monitor your health, how well the new liver is working, and to check for any signs of cancer returning. You will also be asked about your quality of life at different points during this time. The study will monitor your blood tests, scans, and general well-being for a total of five years after the transplant, including monitoring for any changes in your cancer.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit of this study is that it might offer a chance for longer survival and a better quality of life if your bowel cancer liver tumours cannot be removed by surgery. However, liver transplant surgery is a major operation with significant risks, including infection, bleeding, and potential problems with the new liver. There are also risks for the living donor. You will need to take powerful medications to prevent your body from rejecting the new liver, which can have side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Toronto General Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'living donor liver transplant'?

This is a type of surgery where a healthy person donates a part of their liver to someone who needs a new one. The liver can regrow, so both the donor and recipient's liver portions grow back to full size.

Why is this study only for people whose cancer is 'unresectable'?

This means your liver tumours cannot be removed by standard surgery. This study is trying to find a new option for those who currently have no surgical cure.

Will I still have chemotherapy if I join this study?

Yes, you must have had chemotherapy for at least three months before being considered, and your tumours need to be stable on this treatment.

Do I need to find my own liver donor?

Yes, a healthy and willing living donor must come forward and be evaluated as suitable for the transplant.

What does 'stable on chemotherapy' mean for my cancer?

It means your liver tumours have not grown and may have even shrunk during your recent chemotherapy treatments.

How to find out more

Erin Winter, BSc

erin.winter@uhn.ca 416-340-4800 Official trial record

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