PERIOP-06
A Study of QBECO Versus Placebo in the Treatment of Colorectal Cancer That Has Spread to the Liver
Brief Summary
The goal of this type of clinical trial is t to answer the following question: Can the chance of colorectal cancer progressing be lowered by taking a medication, QBECO, before and after surgery? The goal of this study is to find out if this approach is better or worse than the standard of care for your type of cancer. The standard of care is defined as care most people get for metastatic colorectal cancer. There is currently no standard of care drug being given before or after surgery to prevent further spread of your cancer. Participants will be asked to self-inject the study medication before surgery for minimum of 11 days and after surgery for minimum of 41 days. Participants will be followed up every 3 months for 2 years, with a final visit at year 5.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older at time of enrollment.
- Pathologic diagnosis of colorectal carcinoma with clinical diagnosis of liver metastases
- Planned to undergo resection of liver lesions for complete clearance of all visible metastatic disease. This will include those who may undergo synchronous resection of the primary colorectal cancer and/or those who may receive a combination of surgery and ablation to treat all lesions.
- Computerized Tomography (CT) of the chest, abdomen, and pelvis with intravenous (IV) contrast within 6 weeks prior to enrollment.
- MRI of the liver within 6 weeks prior to enrollment OR within 6 weeks prior to starting neoadjuvant chemotherapy (for patients treated with chemotherapy).
- Planned to receive the last dose of neoadjuvant chemotherapy at least 25 days prior to surgery (for patients treated with neoadjuvant chemotherapy).
- Agree to comply with the contraceptive requirements of the protocol when applicable
- Willing and able to either perform subcutaneous injections according to the study protocol, or receive the injections from a caregiver delegated by the participant.
- Able to provide informed consent or has a substitute decision maker capable of providing consent on their behalf.
Exclusion Criteria
- Prior or current evidence of extrahepatic metastases.
Overview
Recruitment Status
Recruiting
ClinicalTrials.gov (NCT#)
NCT05677113
Trial contact
cancerclinicaltrials@sunnybrook.ca
Conditions
- Advanced Cancer
- Gastrointestinal Cancer
- Liver Cancer