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REGISTRY TO EVALUATE EFFECTIVENESS AND SAFETY OF THE NANOKNIFE SYSTEM FOR ABLATION OF STAGE 3 PANCREATIC ADENOCARCINOMA

REGISTRY TO EVALUATE EFFECTIVENESS AND SAFETY OF THE NANOKNIFE SYSTEM FOR THE ABLATION OF STAGE 3 PANCREATIC ADENOCARCINOMA

  • Clinical Trial Information

    Trial Contact: De Leon, Ma Theresa; Walton, Sherri

    Trial Phone: 321.841.8284 ; 321.841.1907

  • IRB No: W19.195.06

    Protocol Abbrev: ANGIO Registry

    Principal Investigator: Debashish Bose, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: 2019-ONC-02

    ClinicalTrials.gov ID: NCT03899649

  • Objective

    Primary Effectiveness Objective:
    To evaluate the effectiveness of the NanoKnife System when
    used for the ablation of Stage 3 PC in real world treatment
    settings, by testing the hypothesis that IRE with the
    NanoKnife System improves overall survival (OS).
    Primary Safety Objectives:
    To assess the safety of IRE with the NanoKnife System as
    compared to the SOC arm in terms of:
    •   Time (in months) from enrollment to death or new
    onset of Grade 4 adverse event (AE), and
    •   High-grade (Grade 3 or higher) AEs according to the
    National Cancer Institute (NCI) Common Terminology
    Criteria for Adverse Events (CTCAE) version 5.0 and
    serious adverse events (SAEs), expressed as a
    percentage of subjects and number of events in the
    control and IRE arms.
    Secondary Objectives:
    ● To compare rates of progression free survival (PFS)
    between the IRE and SOC cohorts
    ● To examine IRE procedure-related pain in the IRE
    cohort
    ● To compare cancer-related pain between the IRE and
    SOC cohorts

  • Key Eligibility

    Inclusion Criteria:
    1.Provisions of signed and dated informed consent form
    2.Patient is 18 years of age and older
    3.Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria
    4.Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery
    5.Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC
    6.Patient has received 3 months of SOC per each participating institution's guidelines
    7.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    8.Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2.
    9.Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System
    10.Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC

    Exclusion Criteria:
    1.Participation in an interventional trial for pancreatic cancer during the study data collection period
    2.Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy
    3.Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade
    4.Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE