Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

October 27, 2025 updated by: Robert C. Martin, University of Louisville

Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma

Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Principal Investigator:
          • Robert Martin, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)
Procedure: Irreversible Electroporation (IRE)
Non-thermal ablation of tumor
Drug: Gemcitabine
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
Drug: FOLFIRINOX
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Time Frame: 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
Time from first dose until subject has reached 90 days post last active study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days
Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.
Time from first dose date to first date of confirmed disease progression, assessed for 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Investigators

  • Principal Investigator: Robert Martin, MD, PhD, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.0529

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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