Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Phase 1

Recruiting

• Conditions: Pancreas Cancer
• Interventions: Procedure: Irreversible Electroporation (IRE); Drug: Gemcitabine; Drug: FOLFIRINOX

• Registration Number: NCT03484299
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-30
• Study Start: 2018-05-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Progression free survival	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.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States