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).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Wroclaw Medical University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Feb 2022 → ongoing

Decision date (initial)

2024-08-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Medical Research Agency

External identifiers

EU CT number

2024-512487-61-00

EudraCT number

2021-004987-91

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate efficacy and safety of irreversible electroporation (IRE), calcium (CaCl2) electroporation and electrochemotherapy (ECT) in patients with pancreatic cancer.

Secondary objectives 2

1. To evaluate overall survival, decrease of body weight loss and decrease of pain level, as well as quality of life improvement
2. Exploratory objectives: - Biomarkers analysis (Ca 19-9). - Morphology and biochemistry analysis (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin). - The inflammatory response in IRE (irreversible electroporation), ECT (electrochemotherapy) and CaEP (calcium electroporation).

Conditions and MedDRA coding

Unresectable pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 12

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)
12. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.

Secondary endpoints 5

1. Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit.
2. Body weight change in predefined timepoints
3. Pain level (VAS scale)
4. Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF
5. Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wroclaw Medical University

Sponsor organisation

Wroclaw Medical University

Address

Ul. Wybrzeze Ludwika Pasteura 1

City

Wroclaw

Postcode

50-367

Country

Poland

Scientific contact point

Organisation

Wroclaw Medical University

Contact name

Wojciech Kielan

Public contact point

Organisation

Wroclaw Medical University

Contact name

Wojciech Kielan

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications