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

Prior treatment

• 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 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.

Other illness

• 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 known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infections.

Other

• Pregnant patients or those who are nursing an infant

• 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.