Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nivolumab, Irreversible Electroporation.
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.
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.
Interventions
- Drug Nivolumab
Given post-operatively every two weeks for a total of 4 doses. Dose based on weight. - Procedure Irreversible Electroporation
Non-thermal ablation of tumor
Primary outcome measures
- Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment [Time frame: Baseline thru 100 days after receiving last dose]
Secondary outcome measures (2)
- Progression Free Survival [Time frame: Every three months for 4 years.]
- Overall Survival [Time frame: Every three months for 4 years.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Louisville — Louisville
Identifiers
NCT: NCT03080974 · 16.1190