Active not recruitingPHASE2INTERVENTIONAL

A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver

This study, called PERIOP-06, is for people with bowel cancer that has spread to the liver and who are having surgery to remove the cancer. It's testing a new drug named QBECO. The main goal is to find out if taking QBECO before and after your surgery can lower the chance of your cancer progressing (growing or coming back) compared to taking a dummy drug (placebo). There isn't currently a standard drug given before or after surgery to prevent this type of cancer from spreading further. We want to see if QBECO can improve the outcomes for patients like you. Participants will inject the study drug at home before and after surgery and will be followed for up to 5 years.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

115

Start

01 Aug 2023

Estimated completion

01 Feb 2031

Colorectal Cancer Liver Metastases

What is this study about?

This study is looking at carefully at a new treatment called QBECO for people who have bowel (colorectal) cancer that has spread to their liver. When bowel cancer spreads, it often goes to the liver. For many patients, surgery to remove these growths in the liver is a key part of their treatment plan.

The main idea behind this study is to see if giving QBECO around the time of surgery – both before and after – can help prevent the cancer from growing or returning. At the moment, there isn't a standard medication given alongside surgery specifically to stop this kind of cancer from spreading further. The researchers want to compare QBECO with a 'dummy' treatment (called a placebo) to understand if QBECO could be a better way to help patients stay cancer-free for longer after their surgery.

QBECO is designed to boost a natural part of your body's defence system, particularly in your gut and liver. The hope is that by strengthening these defences, QBECO could help your body fight against any cancer cells that might remain after surgery and reduce the chances of the cancer spreading again. This study will help doctors understand more about how QBECO works and if it can improve long-term results for patients.

Key takeaways

Tests a new drug, QBECO, for bowel cancer spread to the liver.
QBECO is given before and after surgery to remove liver tumours.
Aims to see if QBECO can reduce cancer coming back or growing.
Compares QBECO to a dummy drug (placebo).
Involves self-injections and follow-up for up to 5 years.
Could help find new ways to treat this type of cancer.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with bowel cancer that has spread to their liver. You would be considered if you are planning to have surgery to remove all visible cancer growths from your liver. This might include removing the original bowel cancer at the same time, or using a mix of surgery and other treatments to clear all the growths.

To join, you'll need to have had recent scans (CT scan of your chest, tummy, and pelvis, and an MRI of your liver) within six weeks before signing up. If you've had chemotherapy recently, it needs to have finished at least 25 days before your planned surgery. You also need to be willing and able to give yourself injections under the skin, or have someone help you do them.

However, you wouldn't be able to join if your cancer has already spread to other parts of your body outside the liver, or if you've had certain liver treatments in the past. Also, if you've had another type of invasive cancer (not including some very common, less serious skin cancers) in the last five years, or if you have a serious autoimmune disease that needs strong medications, you wouldn't be suitable for this study.

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 or older?
Do you have bowel cancer that has spread only to your liver?
Are you planning to have surgery to remove all visible cancer from your liver?
Are you willing and able to give yourself injections (or have help)?
Have you not had any other invasive cancer in the last 5 years (excluding some skin cancers)?
Have you not had severe autoimmune disease needing strong medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: one receiving QBECO and the other receiving a placebo (a dummy drug that looks like QBECO but contains no active medicine). You won't know which one you're getting, and neither will your doctors.

You'll be asked to give yourself injections under your skin every two days. You'll start these injections between 11 and 120 days before your surgery and continue them for at least 41 days after your surgery. After your surgery and the initial treatment period, you'll have follow-up appointments every three months for two years. There will then be a final check-up five years after your surgery. During these appointments, doctors will closely monitor your health and how you're responding to treatment using scans and blood tests.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new investigational treatment that might help prevent your cancer from returning or growing, which isn't currently available as standard care. However, there's no guarantee that QBECO will be effective for you, and it has not yet been proven to work. As with any medication, there's a risk of side effects, which the study will carefully monitor. You might also have more doctor visits and tests than usual. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (4)

Hamilton Health Science Centre
Verified postcode
Hamilton, Canada
London Health Science Centre
Verified postcode
London, Canada
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Sunnybrook Health Science Centre
Verified postcode
Toronto, Canada

Common questions

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Why do I need to inject the drug myself?

The study drug is given as an injection under the skin, which can be done at home. If you're unable to do it, a caregiver can help you.

How long will I be involved in the study?

You'll take the study medication for a period before and after surgery, and then you'll be followed up for a total of 5 years after your surgery.

Can I still receive my usual chemotherapy if I join?

The study design allows for you to have received chemotherapy before your surgery, as long as it finished at least 25 days before your operation.

What happens if the cancer spreads to other parts of my body during the study?

If the cancer spreads outside the liver, you would unfortunately no longer be able to continue in the study.