Could a simple injection before and after surgery keep colorectal cancer at bay?
NCT ID NCT05677113
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests whether a drug called QBECO, given as a self-injection before and after liver surgery, can lower the chance of colorectal cancer coming back or spreading. About 115 adults with colorectal cancer that has spread to the liver will take part. They will inject the drug for at least 11 days before surgery and 41 days after, then be followed for up to 5 years. The goal is to see if this approach improves cancer control compared to standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 115 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Feb 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Patients with small (\<1.0 cm) indeterminate pulmonary nodules may be included at the investigator's discretion. * Prior hepatic arterial infusion or embolization. Prior portal vein embolization, ablation, or liver resection are permitted. * Patients with any invasive cancer history other than colorectal cancer in the last 5 years. In situ disease (e.g., melanoma in situ, ductal carcinoma in situ of the breast) or non melanoma skin cancers are permitted. * Patients with a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents. This includes patient requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent, or depot corticosteroids in the 6 weeks before enrollment) or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporine, etc.) within the 14 days prior to enrollment or a reasonable expectation that the patient may require such treatment during the course of the study. Inhaled or topical or inter-articular steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. Steroids used for premedication prior to chemotherapy or as part of a chemotherapy regimen are allowed. * Patients with known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infections. * Pregnant patients or those who are nursing an infant
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hamilton Health Science Centre
Hamilton, Ontario, Canada
-
London Health Science Centre
London, Ontario, Canada
-
Sunnybrook Health Science Centre
Toronto, Ontario, L4H1Z9, Canada
-
The Ottawa Hospital
Ottawa, Ontario, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lab test tell which chemo works for colon cancer?
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?