Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Liver Metastasis Colon Cancer
Interventions
COMBINATION_PRODUCT

IRE plus checkpoint inhibitor

Nivolumab: Patients will receive 240 mg nivolumab (dissolved in 250 mL NaCl 0.9%) administered intravenously over 30 minutes. The first dose will take place one or two days before the IRE treatment. The second and third doses will be given 2 and 4 weeks post-IRE. Bloodwork will be done just prior to each treatment.

COMBINATION_PRODUCT

IRE plus Checkpoint Inhibitor plus CpG-ODN

"Patients will receive 240 mg nivolumab as above and also receive 8 mg of CpG-ODN dissolved in 1 mL normal saline administered peritumorally just before the IRE treatment. Three or four electrodes will be placed using a combination of ultrasound and CT guidance in preparation for treatment. Then using the electrodes as landmarks, injection of ¼ or 1/3 cc of the CpG solution will be performed near each of the 3 or 4 electrodes to achieve a peritumoral administration of the drug.~IRE is performed in the CT scanner. Patients will receive a general anesthetic and an ultrasound will be performed to locate the designated metastasis. Ultrasound-guided electrode placement (3 or 4 depending on cancer size, shape, and location) will be performed by interventional radiologist Dr. Chris Wall and the IRE device will be activated and used as per the technique of Martin et al."

All Listed Sponsors
lead

University of Saskatchewan

OTHER