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

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Placebo, QBECO

Tags

MSI-H/ MMRd, MSS/ MMRp
Location Location Status
Canada
Hamilton Health Science Centre
Hamilton, Ontario
Not yet recruiting
London Health Science Centre
London, Ontario
Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario
Recruiting
Sunnybrook Health Science Centre
Toronto, Ontario L4H1Z9
Recruiting

Contacts

Ellen Green
CONTACT
egreen@qubiologics.com

Inclusion 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

Exclusion Criteria:

* Prior or current evidence of extrahepatic metastases. Patients with small (

NCT ID

NCT05677113

Date Trial Added

2023-01-10

Updated Date

2025-01-29