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NCT03080974 | RECRUITING | Pancreatic Adenocarcinoma

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Sponsor:

University of Louisville

Information provided by (Responsible Party):

Robert C. Martin

Brief Summary:

Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Condition or disease

Pancreatic Adenocarcinoma

Intervention/treatment

Nivolumab

Irreversible Electroporation

Phase

PHASE2

Detailed Description:

Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a Phase II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Actual Study Start Date : 2017-08-14
Estimated Primary Completion Date : 2025-06-01
Estimated Study Completion Date : 2026-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * ≥ 18 years if age
  • * Diagnosed with stage III pancreatic cancer
  • * Tumor is measurable
  • * Glomerular Filtration Rate \> 60 m/L/min/1.73 m(2)
  • * Willing and able to comply with the protocol requirements
  • * Able to comprehend and have signed the informed consent to participate
Exclusion Criteria
  • * Participating in another clinical trial for the treatment of cancer at time of screening
  • * Are pregnant or currently breast feeding
  • * Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the 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
Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Location Details

NCT03080974

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Locations

RECRUITING

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202