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

Launched by UNIVERSITY OF SASKATCHEWAN · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with stage IV colorectal cancer that has spread to the liver. Specifically, it combines a procedure called irreversible electroporation (IRE), which uses electrical pulses to destroy cancer cells, with immune-boosting drugs. The main goals of the trial are to see how safe this combination is, how it affects the size of other liver tumors that aren't directly treated with IRE, and how well the immune system responds to this treatment.

To participate in the trial, patients need to have certain characteristics, such as having liver tumors that are small enough and accessible for the IRE treatment. Additionally, they should have already undergone chemotherapy and have tumors that cannot be surgically removed. The trial will not be recruiting patients just yet, but once it begins, participants can expect to receive the new treatment and have regular check-ups to monitor their health and response to the therapy. It's important for potential participants to understand the eligibility requirements and to be willing to provide informed consent before joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Prior resection of the colorectal cancer primary.
• • 3. The imaging has been reviewed in multi-disciplinary Rounds and the colorectal liver metastases have been deemed unresectable.
• • 4. Patient has undergone chemotherapy and has not converted to resectable disease.
• • 5. 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)
• • 6. Microsattelite instability (MSI)-stable or mismatch-proficient tumors
• • 7. Patient has HLA phenotype of Human Leukocyte Antigen (HLA) A1 or HLA A2.
• • 8. Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • 1. Size of the metastasis being treated with IRE \> 3.2 cm or \< 2 cm.
• • 2. Size of any non-IRE-treated liver metastasis \> 4 cm
• • 3. Pregnancy
• • 4. Major comorbid disease
• • 5. Active autoimmune disease
• • 6. Bone or brain or peritoneal metastases.
• • 7. MSI High disease
• • 8. Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.
• • 9. Metal implant that cannot be removed within 10 cm of the area to be treated.
• • 10. Peritoneal disease.
• • 11. Poor performance status
• • 12. Cirrhosis