A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Study Overview
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Brief Summary
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This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) [IRE cohort], and patients who were treated with SOC and did not receive IRE [SOC cohort].

Official Title
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Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

Conditions
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Stage III Pancreatic Cancer

Intervention / Treatment
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* Drug: SOC
* Device: NanoKnife System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provisions of signed and dated informed consent form Patient is 18 years of age and older Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC Patient has received 3 months of SOC per each participating institution's guidelines Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1 or 2. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC Exclusion Criteria: Participation in an interventional trial for pancreatic cancer during the study data collection period 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 Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IRE Cohort<br>Patients who received SOC and received IRE | Drug: SOC<br>* Standard of Care treatment<br>Device: NanoKnife System<br>* Irreversible Electroporation<br>|
| SOC Cohort<br>Patients who received SOC and did not receive IRE | Drug: SOC<br>* Standard of Care treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | 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) | Time (in months) from time of enrollment to the date of death for any reason, assessed up to 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAPC, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Advanced Pancreatic Cancer, Carcinoma, Pancreatic Ductal, Locally Advanced Pancreatic Cancer, Cancer of Pancreas, Pancreatic Tumor, Pancreatic Carcinoma, Unresectable Pancreatic Cancer