Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer

University of Verona

Status: Terminated

Conditions: Pancreatic Cancer

Treatments: Device: Electrochemotherapy with Bleomycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03225781

SP-ECT

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced CT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure
• Cytohistological diagnosis of pancreatic cancer
• Age > 18 and < 80
• Stable disease after chemotherapy (no tumor progression, no oncomarkers (Carbohydrate Antigen 19-9 [CA 19-9] or Carcinoembryonic antigen [CEA]) increase
• Performance Status 0 sec. ECOG (Eastern Cooperative Oncology Group)
• Written informed consent

Exclusion criteria

• Resectable pancreatic cancer as assessed by multidisciplinary meeting
• Stage IV disease
• Patients receiving fenitoin, phosphofenitoin or living vaccines
• Pregnancy
• Progressive disease (either dimensional and not only by stage)
• < 18 years old and > 80

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)