Effects of calcium electroporation, electrochemotherapy, and irreversible electroporation of life and progression in patients with pancreatic cancer.

Phase 1

• Conditions: nresectable pancreatic cancer; MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-004987-91-PL
• Lead Sponsor: niwersytet Medyczny im. Piastów Slaskich we Wroclawiu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1.Age over 18 years (male and female)
2.Written informed consent
3.Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible)
4.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
5.Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days
6.Patients undergoing chemotherapy or patients with a de novo” diagnosis of pancreatic cancer
7.ECOG performance status: 0,1 or 2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1.Age under 18 years.
2.Inability to give consent in writing.
3.Pregnant or lactating women
4.Significant cardiac abnormality (rhythm other than sinus rhythm).
5.Patients with pacemakers or any implanted stimulation device.
6.Allergy to contrast media that would compromise the ability to perform imaging after surgery.
7.Documented history of allergy to bleomycin.
8.Documented history of pulmonary fibrosis.
9.Patient with metastatic stage IV disease.
10.INR > 1,5 without use of anticoagulants.
11.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).
13.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified