NCT06047015Not yet recruitingPhase 1/2
Irreversible Electroporation (NanoKnife ®) and Immunotherapy for the Treatment of Stage IV Colorectal Cancer
Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this pilot clinical trial is to learn about the combination of immune boosting drugs and irreversible electroporation (IRE) in patients with colon cancer that has spread to the liver (metastasis). The main questions it aims to answer are: 1. to document the rate of complications associated with combining IRE with immune boosting drugs. 2. After one liver metastasis is treated with IRE and immune boosting drugs, what is the change in the size of the non-IRE-treated liver metastases? 3. What is the immune response (measured in a blood sample) when IRE is combined with one or two types of immune boosting drugs?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 21 Feb 2023
- Start date
- Jul 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Saskatchewan
- Diseases
- Colorectal cancer, Childhood cancers
- NCT number
- NCT06047015
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From Jul 2025 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Size of the metastasis being treated with IRE \> 3.2 cm or \< 2 cm.
- Metal implant that cannot be removed within 10 cm of the area to be treated.
Other illness
- Major comorbid disease
- Active autoimmune disease
- MSI High disease
- Patients with cardiac arrhythmia other than rate controlled atrial fibrillation.
- Peritoneal disease.
Other
- Size of any non-IRE-treated liver metastasis \> 4 cm
- Pregnancy
- Bone or brain or peritoneal metastases.
- Poor performance status
- Cirrhosis
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.