Study on the Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

Sponsor: Angiodynamics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03899636

Provider View

This clinical trial is testing a new treatment method called NanoKnife IRE for patients with Stage 3 pancreatic cancer. Participants will receive chemotherapy and may also receive the NanoKnife IRE treatment to see if it improves outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment for Stage 3 pancreatic cancer using a device called the NanoKnife. Participants will be randomly assigned to one of two groups: one group will receive chemotherapy alone, and the other group will receive chemotherapy followed by the NanoKnife treatment. The NanoKnife uses a technique called irreversible electroporation (IRE) to target cancer cells. All participants will first receive chemotherapy for at least three months. After this period, they will be evaluated to ensure their cancer has not progressed before being assigned to one of the two groups. The study will follow participants for at least 24 months or until they pass away to monitor the treatment's effectiveness and safety.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of Stage 3 pancreatic cancer that cannot be surgically removed.
  • Tumor must be classified as Stage 3 based on specific medical guidelines.
  • Tumor size must be 3.5 cm or smaller after three months of chemotherapy.
  • Must have completed three months of chemotherapy with the modified FOLFIRINOX regimen.
  • Must be in good overall health, with a performance status score of 0 or 1.
  • Must have a physical health status classification of 1 or 2 according to specific medical standards.

Exclusion Criteria

  • Women who are pregnant or breastfeeding, or individuals not using effective birth control.
  • Individuals who cannot tolerate general anesthesia.
  • Individuals with certain blood conditions, such as low hemoglobin or platelet counts.
  • Individuals with implanted electronic devices like pacemakers.
  • Individuals with a history of epilepsy or other neurological disorders.
  • Individuals with significant kidney, heart, liver, or blood disorders.
  • Individuals with advanced chronic kidney disease.
  • Individuals receiving IRE for specific surgical purposes.
  • Individuals whose cancer has progressed after three months of chemotherapy.
  • Individuals participating in another pancreatic cancer trial.
  • Individuals who did not meet the study's treatment criteria after three months.

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