Recruiting
Phase 1

Chemotherapy & Irreversible Electroporation

Sponsor:

University of Louisville

Code:

NCT03484299

Conditions

Pancreas Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Irreversible Electroporation (IRE)

Gemcitabine

FOLFIRINOX

Study Details

Brief summary:

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

Conditions

Pancreas Cancer

Study ID

NCT03484299

Start date

May 30, 2018

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment

Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)

Interventions

Irreversible Electroporation (IRE)

Non-thermal ablation of tumor

Gemcitabine

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

FOLFIRINOX

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Robert Martin, MD, PhD

502-629-3355robert.martin@louisville.edu

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Robert Martin, MD, PhD

502-629-3355robert.martin@louisville.edu

Principal Investigator:

Robert Martin, MD, PhD

More Information

Sponsor

University of Louisville

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-10-29.