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RecruitingInterventionalPhase 1

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

NCT ID: NCT03484299Sponsor: University of LouisvilleLast updated: 2025-10-29

Summary

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

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.

Arms & interventions

  • ProcedureIrreversible Electroporation (IRE)

    Non-thermal ablation of tumor

  • DrugGemcitabine

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

  • DrugFOLFIRINOX

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

Outcome measures

Primary

  • Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)

    Adverse and Serious Adverse events will be collected and analyzed

    Time frame: Time from first dose until subject has reached 90 days post last active study treatment

Secondary

  • Progression free survival

    Time frame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Louisville

Louisville, Kentucky, 40202

Recruiting
Robert Martin, MD, PhD · Contact
502-629-3355robert.martin@louisville.edu
Robert Martin, MD, PhD · Principal Investigator

References

  • Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17.(PubMed)
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma | Cancerify