Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation (IRE-CaCl2, ECT and IRE) on quality of life and progression – free survival in patients with pancreatic cancer (IREC).

Phase 1

Recruiting

Conditions: nresectable pancreatic cancer
MedDRA version: 21.0Level: LLTClassification code: 10033606Term: Pancreatic cancer non-resectable Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-512487-61-00

Lead Sponsor: Wroclaw Medical University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 73

Inclusion Criteria

Age over 18 years (male and female), Written informed consent, Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible), Lesion defined as unresectable (infiltration of mesenteric or portal vein exceeding 180 degrees or its thrombosis, infiltration of the hepatic artery, celiac artery or superior mesenteric artery) on abdominal CT/MRI not older than 60 days (stage III), or patients after resection with local recurrence of the neoplastic process, Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days, Patients undergoing chemotherapy or patients with a de novo diagnosis of pancreatic cancer, ECOG performance status: 0,1 or 2

Exclusion Criteria

Age under 18 years, INR > 1,5 without use of anticoagulants, Body temperature >38°C or any infection requiring antibiotic therapy within 24 hours prior to study treatment. 12. Overuse or addiction to alcohol, drugs or any other substances (caffeine and nicotine excluded), Any circumstances, that in the Investigator's judgement may prevent the patient from participating in the study, undergoing the study assessments in accordance with the protocol or bear unjustified risk to the patient, Inability to give consent in writing, Pregnant or lactating women, Significant cardiac abnormality (rhythm other than sinus rhythm)., Patients with pacemakers or any implanted stimulation device, Allergy to contrast media that would compromise the ability to perform imaging after surgery, Documented history of allergy to bleomycin, Documented history of pulmonary fibrosis, Patient with metastatic stage IV disease