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ACTIVE NOT RECRUITING
NCT05677113
PHASE2

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

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2023-08-01

Completion Date

2031-02-01

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

QBECO

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.

DRUG

Placebo

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.

Locations (4)

Hamilton Health Science Centre

Hamilton, Ontario, Canada

London Health Science Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada