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NCT Number: NCT03484299

Chemotherapy and Irreversible Electroporation 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.

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Key information

Conditions

Pancreas Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Robert Martin, MD, PhD

CONTACT

[email protected]

502-629-3355

Robert Martin, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irreversible electroporation (IRE)

Procedure

Non-thermal ablation of tumor

Gemcitabine

Drug

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

Folfirinox

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Martin, MD, PhD

CONTACT

[email protected]

502-629-3355

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2027
First posted
Mar 30, 2018
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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