RecruitingPHASE2INTERVENTIONAL

Conversion From Unresectable To Resectable Metastatic Colorectal Cancer.

This study is for people in the UK with bowel cancer that has spread only to their liver and can't currently be removed by surgery. Usually, treatments in this situation can only help manage the cancer. We're looking at a specific combination of chemotherapy medicines, FOLFOXIRI, along with another drug called bevacizumab. The main goal is to see if this treatment can shrink the liver tumours enough that surgeons can then safely remove them. If successful, this could offer a chance for a long-term cure, which is rare for this type of advanced cancer. The study will also check to see how the treatment affects quality of life and if certain tests can predict who will benefit most from surgery.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Saskatchewan

Enrolment target

Start

01 May 2025

Estimated completion

31 Dec 2026

Metastatic Colorectal Cancer

What is this study about?

Bowel cancer is a common type of cancer, and sometimes it can spread to other parts of the body. When it spreads to the liver, it's called metastatic colorectal cancer. For most people with this condition, treatment focuses on managing the cancer and keeping them comfortable. However, if the cancer has only spread to the liver, and if those parts can be completely removed by surgery, there's a chance for a long-term cure.

Currently, many people whose bowel cancer has spread to the liver can't have surgery because the tumours are too large or in difficult places. This study is exploring a new approach. We're testing a combination of strong chemotherapy drugs called FOLFOXIRI, along with another medicine called bevacizumab. The idea is that this powerful combination might shrink the liver tumours significantly, turning an "unresectable" (not surgically removable) situation into a "resectable" (surgically removable) one.

This study aims to find out how often this treatment combination can make surgery possible. We'll also be looking at whether certain scans (like a special FDG-PET/CT scan) or other checks can tell us early on which patients are most likely to respond well and be able to have surgery. Ultimately, if we can successfully shrink these liver tumours and allow them to be removed, it could offer a much better outlook for people in this situation.

Key takeaways

Targets bowel cancer that has spread only to the liver and can't be surgically removed.
Investigates a strong combination of chemotherapy (FOLFOXIRI) and another drug (bevacizumab).
Aims to shrink tumours so surgery becomes possible, potentially offering a cure.
Includes regular scans to monitor treatment progress.
Will assess how the treatment affects quality of life.
Could help establish a new standard treatment for this specific type of cancer.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old. You must have bowel cancer that has spread only to your liver, and your doctors must have told you that these liver tumours cannot be removed by surgery right now. You shouldn't have any cancer elsewhere in your body apart from the liver.

Your general health needs to be good enough to handle the treatment, meaning your body, especially your blood, liver, and kidneys, are working well. You also shouldn't have received any chemotherapy for your advanced cancer before joining this study.

There are also reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, you cannot participate. Also, if you have other serious illnesses that are not well controlled, or if you have another active cancer (except for certain skin cancers), this study won't be suitable 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.

Are you between 18 and 70 years old?
Do you have bowel cancer that has spread only to your liver?
Have your doctors said your liver tumours cannot currently be removed by surgery?
Have you not had chemotherapy for your advanced cancer yet?
Are you generally well and fit enough for treatment?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the new treatment called FOLFOXIRI and bevacizumab. This treatment is given every two weeks, and you would receive a total of 12 treatment cycles. Each cycle involves coming to the hospital for your medication.

Throughout the study, you'll have regular medical checks and imaging scans, like CT or MRI scans, to see how the treatment is working and if the tumours are shrinking. A team of specialists, including surgeons, radiologists, and cancer doctors, will regularly review your scans to determine if your liver tumours have become small enough to be removed by surgery. If surgery becomes an option, your team will discuss this with you. The study will also look at your quality of life. The total duration of your participation in the study will depend on how you respond to treatment and whether you have surgery.

Potential risks and benefits

Taking part in this study could offer a significant benefit: the chance for your liver tumours to shrink enough to allow potentially curative surgery. This is a possibility that might not exist with standard treatments alone. However, treatments like FOLFOXIRI and bevacizumab can have side effects, as they are powerful medications. These can vary from person to person but your care team will monitor you closely and manage any side effects. As with any clinical trial, there's no guarantee that the treatment will work for you, or that you'll be able to have surgery. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Allan Balir Cancer Center
Verified postcode
Regina, Canada· Recruiting

Common questions

What is 'unresectable' liver cancer?

It means the cancer in your liver can't be removed with surgery at the moment, usually because of its size, number, or location.

What are FOLFOXIRI and bevacizumab?

They are different types of anti-cancer medicines. FOLFOXIRI is a combination of several strong chemotherapy drugs, and bevacizumab is another drug that targets blood vessel growth in tumours.

What does 'Phase 2' mean?

Phase 2 means this is an early study to see if the treatment works and is safe. The main goal is to find out if it's effective enough to move onto larger studies.

Will I still receive my usual care if I join?

Yes, you will continue to receive good medical care from your doctors whether you join the study or not. This study is an additional treatment option.

Where is this study taking place?

This study is recruiting patients at two main cancer centres in Saskatchewan. You would need to be able to attend appointments at one of these locations.

How to find out more

Shahid Ahmed, MD, PhD

shahid.ahmed@saskcancer.ca 3066552710 Official trial record

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