What is the PERIOP-06 Study about?
Surgical removal of cancer that has spread to the liver can potentially be curative for patients whose colorectal cancer has metastasized to the liver. However, surgery can temporarily suppress or weaken the immune system, making the immune system less able to destroy cancer cells that might remain after surgery and increasing the chances of further cancer spread.
The PERIOP-06 Study is evaluating a new immunomodulator designed to strengthen natural immune function to prevent immune suppression caused by surgery and improve cancer outcomes in patients with colorectal cancer undergoing surgery for liver metastases.
What is the Study evaluating?
Just like our muscles, our innate immune system benefits from training. Our immune system relies on beneficial exposure to bacteria for this training, making our innate immune system stronger and more resilient.
The PERIOP-06 Study is evaluating an immunomodulator, made from inactivated bacteria, designed to train and strengthen the immune system to prevent the immune suppression that occurs with surgery, reduce the chance of cancer progression, and improve overall cancer outcomes in patients with metastatic colorectal cancer.
What does the Study involve?
- Study treatment period before and for 42 days after surgery
- Immune monitoring (blood will be collected 8 times)
- Tissue sampling (collected during surgery)
- Regular interactions and support from clinical study staff
Who can participate?
- You may be eligible to participate if you:
- have colorectal cancer planning to have surgery for removal of liver metastases
- live in Ontario, Canada
Who is conducting the Study?
PERIOP-06 clinical trial is led by Gastroenterology (GI) surgeons:
- Dr. Rebecca Auer (Executive Vice-President of Research and Innovation, Ottawa Hospital, and CEO of Ottawa Hospital’s Research Institute)
- Dr. Paul Karanicolas (Co-Director, Centre for Clinical Trial Support, Sunnybrook Health Sciences Centre)
Collaborators
This Clinical Study is a collaboration with Qu Biologics, Sunnybrook Health Sciences Centre, Ottawa Hospital Research Institute, University Health Network, London Health Sciences Centre and Hamilton General Hospital. This Study is supported by the Canadian government through the Accelerating Clinical Trial (ACT) Canadian Consortium.