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Not yet recruiting NCT06047015

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

Phase I / Phase II Interventional Liver Metastasis Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IRE plus checkpoint inhibitor, IRE plus Checkpoint Inhibitor plus CpG-ODN.
Who it may be relevant to
Registry conditions: Liver Metastasis Colon Cancer. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Immune Response to Irreversible Electroporation (NanoKnife ®) and a Checkpoint Inhibitor With or Without CpG Oligodeoxynucleotides for the Treatment of Stage IV Colorectal Cancer

Overview

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?

Detailed description

Single-centre pilot study of the use of IRE for the treatment of 12 patients with unresectable colorectal liver metastases to assess feasibility and gain preliminary data to inform the design of a larger study.

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

Primary outcome measures

  • Complications [Time frame: 30 days]
  • Complications [Time frame: 90 days]
  • Abscopal effect: percent change in non-treated colorectal liver metastasis. [Time frame: 3 months from the time of IRE]
Secondary outcome measures (11)
  • Tumor-specific immune response: distribution on flow-cytometry plot [Time frame: Day 8]
  • Tumor-specific immune response: serum cytokine concentrations [Time frame: Day 8]
  • Tumor-specific immune response: distribution on flow-cytometry plot. [Time frame: Day 14]
  • Tumor-specific immune response: serum cytokin concentrations [Time frame: Day 14]
  • Tumor-specific immune response: distribution on flow-cytometry plot. [Time frame: Day 30]
  • Tumor-specific immune response [Time frame: Day 30]
  • Progression-free survival [Time frame: 1 year]
  • Progression-free survival [Time frame: 2 years]
  • Quality of life questionnaire [Time frame: baseline]
  • Quality of life questionnaire [Time frame: 12 weeks]
  • Quality of life questionnaire [Time frame: 1 year]

Eligibility 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

  • Size of the metastasis being treated with IRE > 3.2 cm or < 2 cm.
  • Size of any non-IRE-treated liver metastasis > 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06047015 · IREIMMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗