NCT04281290

Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study)

Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy (ECT) with bleomycin in pancreatic cancer in clinical study phase I and II. After surgical resection of pancreatic cancer, the posterior resection surface will be treated with ECT with the intention to lower disease recurrence rate. The study will include 10patients in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria. Treatment effectiveness will be evaluated by US or CT imaging, to detect early local recurrence of the disease. Long term effectiveness of the treatment will be evaluated by frequent and precise patient follow-up. During follow-up clinical examination, laboratory tests, tumor markers (Ca 19-9 and CEA) and US/CT imaging will be performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.

Detailed description

The study will be conducted on patients with resectable pancreatic cancer. 10patients will be included in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study). After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes. ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart. All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
PROCEDURE	Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)	Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses. Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes. The maximum duration of procedure is 90 minutes, after liver mobilization. Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2)

Timeline

• Start date: 2020-07-13
• Primary completion: 2023-05-08
• Completion: 2026-05-08
• First posted: 2020-02-24
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: Slovenia