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Pilot study at just one location in Canada, for 12 patients. It will use a technique called IRE (irreversible electroporation) to ablate a liver metastases that is unresectable, and patients will receive also one or two immunotherapies.
6 patients undergo IRE and receive nivolumab (anti PD-1, Opdivo); 6 patients undergo IRE and receive nivolumab and CpG Oligodeoxynucleotides (CpG-ODN).
Key inclusion criteria: at least one CRC liver met measuring < 3.5 cm in diameter (but < 2 cm is excluded), to be treated with IRE. Any non-IRE-treated liver metastasis > 4 cm is an exclusion criterion.

The study aims to observe if non-IRE-treated lesions shrink after one liver met is treated with IRE and immune boosting drugs; also: what is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?

Helpful Links

https://www.mdpi.com/2072-6694/15/9/2428 https://www.tandfonline.com/doi/full/10.1080/02656736.2021.2008025 https://link.springer.com/article/10.1007/s00270-021-02981-4 Electroporation and Immunotherapy—Unleashing the Abscopal Effect

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Inclusion Criteria

Inclusion Criteria:

Biopsy-proven colorectal liver metastases with at least one measuring < 3.5 cm in diameter and accessible to percutaneous IRE such that a complete ablation of the lesion is possible.
Prior resection of the colorectal cancer primary.
The imaging has been reviewed in multi-disciplinary Rounds and the colorectal liver metastases have been deemed unresectable.
Patient has undergone chemotherapy and has not converted to resectable disease.
Radiologic evidence of stable disease for at least two months on systemic therapy for colorectal cancer (may have had prior partial response or disease progression)
Microsattelite instability (MSI)-stable or mismatch-proficient tumors
Patient has HLA phenotype of Human Leukocyte Antigen (HLA) A1 or HLA A2.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Exclusion Criteria:

Size of the metastasis being treated with IRE > 3.2 cm or 4 cm
Pregnancy
Major comorbid disease
Active autoimmune disease
Bone or brain or peritoneal metastases.
MSI High disease
Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.
Metal implant that cannot be removed within 10 cm of the area to be treated.
Peritoneal disease.
Poor performance status
Cirrhosis