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

Estado del programa

Reclutamiento

Fase

Fase 2

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

Placebo, QBECO

Etiquetas

MSI-H/ MMRd, MSS/ MMRp
Ubicación Situación
Canadá
Hamilton Health Science Centre
Hamilton, Ontario
Aún no se ha contratado
London Health Science Centre
London, Ontario
Aún no se ha contratado
The Ottawa Hospital
Ottawa, Ontario
Reclutamiento
Sunnybrook Health Science Centre
Toronto, Ontario L4H1Z9
Reclutamiento

Contactos

Hal Gunn
CONTACTO
604.734.1450 hal@qubiologics.com
Ellen Green
CONTACTO
egreen@qubiologics.com

Criterios de inclusión

Criterios de inclusión:

* 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.

Criterios de exclusión

Criterios de exclusión:

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

NCT ID

NCT05677113

Fecha en que se añadió el juicio

2023-01-10

Fecha de actualización

2025-03-25