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).
EU CTIS ID: 2024-512487-61-00
What this study is testing
To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.