The trial investigates the safety and efficacy of irreversible electroporation in combination with checkpoint inhibition in patients with metastatic pancreatic cancer.
The trial is designed as an investigator initiated prospective phase 2 study in patients with metastatic pancreatic cancer (PC) to determine the efficacy and safety of checkpoint inhibition administered concurrently with irreversible electroporation. A recently published preclinical study by Zhao et al. (2019) showed that the combination of IRE and PD-1-inhibitor suppressed the tumour growth and increased the survival of mice bearing pancreatic cancer. The aim of the trial is to initiate an abscopal response, leveraging the patient's immune system in eliciting a sufficient immune response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Every 2 weeks (3 mg/kg, maximum of 240 mg) for up to 24 weeks Nivolumab is an immune checkpoint inhibitor (PD-1-inhibitor).
Percutaneous ablation of a primary in-situ (or locally-recurrent) or metastatic lesion. Irreversible electroporation is delivered through the NanoKnife system (AngioDynamics, New York, USA). The system is FDA-approved for medical use.
Zealand University Hospital
Roskilde, Denmark
Incidence of treatment related adverse events [Safety and Tolerability]
Determined by the incidence and severity of treatment related adverse events according to CTCAE version 4.0
Time frame: 6 months after start of treatment
Tumor response by CT
Based on CT chest/abdomen scans according to RECIST version 1.1
Time frame: Baseline compared to 3 and 6 months after start of treatment
Tumor response by ultrasound
Based on contrast enhanced ultrasound (CEUS) utilizing the standardized and quantitative method Dynamic CEUS (DCEUS)
Time frame: Baseline compared to 3 and 6 months after start of treatment
Progression free survival
In terms of months
Time frame: From start of treatment until unequivocal disease progression, assessed up to 5 years
Overall survival
In terms of months
Time frame: From start of treatment until unequivocal disease progression, assessed up to 5 years
Quality of life using EORTC QLQ-C30
EORTC QLQ-C30
Time frame: Baseline compared to 14 days, 3 and 6 months after start of treatment
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