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

计划状态

招聘

阶段

第二阶段

允许先接受免疫治疗

没有

CRC 指导的试验

药物

Placebo, QBECO

标签

MSI-H/ MMRd、MSS/ MMRp
地点 位置状态
加拿大
Hamilton Health Science Centre
Hamilton, Ontario
尚未招聘
London Health Science Centre
London, Ontario
尚未招聘
The Ottawa Hospital
Ottawa, Ontario
招聘
Sunnybrook Health Science Centre
Toronto, Ontario L4H1Z9
招聘

联系方式

Ellen Green
联系
egreen@qubiologics.com

纳入标准

纳入标准

* 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.

排除标准

排除标准:

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

NCT ID

NCT05677113

添加审判日期

2023-01-10

更新日期

2025-03-25