Health TrialsbyHealthPanel

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

ConditionPancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years if age

Diagnosed with stage III pancreatic cancer

Tumor is measurable

Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.

  • Irreversible Electroporation

    Procedure/Surgery

    Non-thermal ablation of tumor

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and Tolerability of Combination Irreversible Electroporation and Nivolumab Treatment

Adverse events and Serious adverse events will be collected

Time frame
Baseline thru 100 days after receiving last dose

Secondary outcomes

1

Progression Free Survival

CT scans will be reviewed

Time frame
Every three months for 4 years.
2

Overall Survival

CT scans will be reviewed

Time frame
Every three months for 4 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Louisville

Lead sponsor

Source ClinicalTrials.gov
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