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

NCT05677113 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 4023
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the 2-year Progression-Free Survival (PFS) rate

  PFS will be defined as the time from enrollment to the first event that is either locoregional recurrence (of the resected primary colorectal adenocarcinoma or the resected ± intraoperatively ablated metastatic disease), distant metastases, or death from any cause. Section 5 further defines PFS and its measurement.

  2 years

Secondary Outcomes (4)

• Clearance of ctDNA.

  5 years

• Side-effect profile of QBECO

  through study completion, an average of 5 years

• Quality of recovery

  Baseline; postoperative day 3, and 6 weeks postoperatively

• Five-year overall survival

  5 years

Study Arms (2)

QBECO

EXPERIMENTAL

QBECO is an SSI formulated from inactivated E. coli bacteria that is specifically designed to target pathologies of the gastrointestinal (GI) tract and related organs, such as the liver. This trial will test the hypothesis that in patients undergoing resection of colorectal liver metastases (CRLMs), perioperative treatment with QBECO will attenuate the postoperative immune suppression and will improve progression-free survival (PFS).

Drug: QBECO

Placebo

PLACEBO COMPARATOR

A placebo is a liquid that looks like the study drug, but contains no medication.

Drug: Placebo

Interventions

QBECO DRUG

QBECO is a site specific immunomodulator (SSI) designed to promote innate immune responses in the gastrointestinal tract and related organs, including the liver. QBECO will be administered according to the following regimen: 0.1mL self-administered subcutaneous injections every 2 days for 11-120 days preoperatively, and 41 days postoperatively.

QBECO

Placebo DRUG

Placebo will be prepared in the same way as the IP. Placebo will be administered according to the following regimen: 0.1mL self-administered subcutaneous injections every 2 days for 11-120 days preoperatively, and 41 days postoperatively.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (4)

Hamilton Health Science Centre

Hamilton, Ontario, Canada

Location

London Health Science Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, L4H1Z9, Canada

Location

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Related Links

• The Multiple Organ Dysfunction Syndrome.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Paul Karanicolas

  Paul.Karanicolas@sunnybrook.ca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: January 10, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CA (4)