Chemotherapy and Irreversible Electroporation for Advanced Pancreatic Cancer

This study is looking at how safe and effective a treatment called Irreversible Electroporation (IRE) is when combined with chemotherapy for people with advanced pancreatic cancer. IRE is a procedure that uses electrical pulses to destroy tumor cells. You would receive either Gemcitabine or FOLFIRINOX chemotherapy along with IRE. Researchers want to see how many side effects occur and how well you tolerate the treatment. To join, you must be at least 18 years old, have stage III pancreatic cancer that can be measured, and meet certain health requirements. The study aims to enroll 20 participants, but its current status is unclear.

Study design
This is a Phase II interventional study that will enroll 20 participants. All participants will receive IRE and either FOLFIRINOX or Gemcitabine.
What's involved
You would receive IRE and chemotherapy. Safety and tolerability will be measured from your first dose until 90 days after your last study treatment.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be monitored for 90 days after your last study treatment.

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NCT03484299

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Louisville
~20 participants
Updated 2025-10-29 on ClinicalTrials.gov
What's tested:Irreversible Electroporation (IRE)GemcitabineFOLFIRINOX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Measured over Time from first dose until subject has reached 90 days post last active study treatment
Pancreas Cancer
1 sites across 1 states
Kentucky1
  • Robert Martin, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville

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Eligibility criteria

Inclusion

greater than or equal to 18 years of age
diagnosed with stage III pancreatic cancer
tumor is measurable
GFR \> mL/min/1.73m2
willing and able to comply with protocol requirements
AST/ALT \>3 times upper limit of normal
stable surgical post-operative course as defined by operative surgeon

Exclusion

participating in another clinical trial for the treatment of cancer at the time of screening
pregnant or currently breast feeding
have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
have non-removable implants with metal parts within 1 cm of the target lesion
had a myocardial infarction within 3 months prior to enrollment
  • Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)Time from first dose until subject has reached 90 days post last active study treatment

    Adverse and Serious Adverse events will be collected and analyzed