Using QBECO to treat colorectal cancer that has spread to the liver

A Phase II Study of Perioperative QBECO Site Specific Immunomodulator (Qu Biologics®) in Patients With Metastatic Colorectal Adenocarcinoma Within the Liver Undergoing Resection

This study is testing if a new treatment called QBECO can help adults with colorectal cancer that has spread to the liver live longer and feel better after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 4 sites (Hamilton, Ontario and 3 other locations)
• Trial ID: NCT05677113 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of QBECO, an immunomodulator, in improving progression-free survival in adults undergoing surgery for colorectal liver metastases. Participants will self-inject QBECO or a placebo before and after their surgery, with follow-up assessments every three months for two years. The study will also investigate the impact of QBECO on circulating tumor DNA and overall survival rates. Approximately 115 participants will be randomized to receive either the investigational drug or a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of colorectal cancer that has spread to the liver, who are scheduled for surgical resection of liver lesions.

Not a fit: Patients who do not have colorectal cancer with liver metastases or those not planning to undergo surgery will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer progression in patients undergoing surgery for colorectal cancer with liver metastases.

How similar studies have performed: While this approach is based on promising preclinical and clinical data, it is a novel investigation specifically targeting colorectal cancer with liver metastases.

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. 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

Where this trial is running

Hamilton, Ontario and 3 other locations

• Hamilton Health Science Centre — Hamilton, Ontario, Canada (Not_yet_recruiting)
• London Health Science Centre — London, Ontario, Canada (Not_yet_recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
• Sunnybrook Health Science Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Paul Karanicolas — [e-mail]
• Study coordinator: Hal Gunn

Conditions Colorectal Cancer; Liver Metastases