Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator"). In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin
University of Verona Hospital
Verona, Italy
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of adverse events related with electrochemotherapy (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications are distinct in early (during hospitalization) and late (bile duct stenosis) that may appear during follow-up
Time frame: through study completion, 1 year
Feasibility
Number of procedures planned actually performed
Time frame: through study completion, 1 year
Tumour response
Analysis of effects of electrochemotherapy on tumor using RECIST criteria
Time frame: 12 months
Quality of life
Analysis of quality of life using the Karnovsky performance index
Time frame: 12 months
Quality of life
Analysis of quality of life using the pain numeric scale
Time frame: 12 months
Survival
Survival analysis through the calculation of overall survival
Time frame: 12 months
Survival
Survival analysis through the calculation of progression free survival survival
Time frame: 12 months
Immunomonitoring
Study of adaptive immunity through the sampling of Interleukin6 and Heat shock protein 70 levels at baseline and post-procedure
Time frame: From baseline to the first month
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