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

NCT04281290 | Active Not Recruiting Results DMC

• 1 other identifier: 21K/01/20
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer

Keywords

Pancreatic cancer; Electrochemotherapy; Bleomycin

Outcome Measures

Primary Outcomes (1)

• Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety

  Every patient will be closely followed-up after operation with clinical examination and blood tests (hemogram, comprehensive metabolic panel, liver panel) according to the study protocol (day 1, 3, 7 after operation). In case of detected abnormalities additional imaging (US and/or CT) will take place. Findings will be noted and reported in line with Clavien-Dindo classification of surgical complications. The primary measure is to detect complications after surgery and to determine whether the complication is related to electrochemotherapy treatment or not.

  7 days after operation

Secondary Outcomes (2)

• Disease-free Survival

  1, 3, 6, 12, 18 and 24 months after operation

• Overall Survival

  From the time of surgical treatment until 5 years after surgery

Study Arms (1)

Experimental group

EXPERIMENTAL

Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Procedure: Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

Interventions

Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) PROCEDURE

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)

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable pancreatic cancer.
• Histologically confirmed and/or based on radiological imaging and laboratory tests confirmed pancreatic cancer by multidisciplinary team for pancreatic tumors.
• Age more than 18.
• Life expectancy more than 3 months.
• Performance status - Karnofsky ≥ 70 or WHO \< or 2.
• Treatment free interval 2-5 weeks, depending on the drugs used.
• Patient must be mentally capable of understanding the information given.
• Patient must give informed consent.
• Patient must be discussed at the multidisciplinary team for pancreatic tumors before entering the trial.

You may not qualify if:

• Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma.
• Proven visceral, bone or diffuse metastases.
• Life-threatening infection and/or heart failure and/or liver failure and/or renal failure (creatinine more than 150 µmol/L) other severe systemic pathologies.
• Significant reduction in respiratory function.
• Age less than 18 years.
• Cumulative dose of 250 mg/m2 bleomycin received.
• Allergic reaction to bleomycin.
• Patients with epilepsy.
• Patients with arrhythmias.
• Patients with heart failure or pacemaker.
• Pregnancy.
• Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Institute of Oncology Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• Cebron Z, Djokic M, Petric M, Cemazar M, Bosnjak M, Sersa G, Trotovsek B. Intraoperative electrochemotherapy of the posterior resection surface after pancreaticoduodenectomy: Preliminary results of a hybrid approach treatment of pancreatic cancer. Bioelectrochemistry. 2024 Feb;155:108576. doi: 10.1016/j.bioelechem.2023.108576. Epub 2023 Sep 22.

  PMID: 37748261 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

Because this is a pilot study, the number of included patients is small (N=10), which represents the main limitation of the research. Due to the small sample size, it is not possible to draw conclusions regarding effectiveness; a larger sample and longer patient follow-up are required. The conclusion regarding safety would also need a larger patient cohort to strengthen our findings.

Results Point of Contact

• Title: Žan Čebron
• Organization: UMC Ljubljana

zan.cebron@kclj.si

0038615224788

Study Officials

• Mihajlo Djokic, MD, PhD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

• Blaz Trotovsek, MD, PhD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  STUDY DIRECTOR

• Gregor Sersa, PhD

  Institute of Oncology, Ljubljana, Slovenia

  STUDY DIRECTOR

• Zan Cebron, MD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  STUDY CHAIR

• Miha Petric, MD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  STUDY CHAIR

• David Badovinac, MD

  University Medical Centre Ljubljana, Ljubljana, Slovenia

  STUDY CHAIR

• Masa Bosnjak, PhD

  Institute of Oncology, Ljubljana, Slovenia

  STUDY CHAIR

• Bostjan Markelc, PhD

  Institute of Oncology, Ljubljana, Slovenia

  STUDY CHAIR

• Maja Cemazar, PhD

  Institute of Oncology, Ljubljana, Slovenia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Žan Čebron, MD, abdominal surgeon

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: February 24, 2020
• Study Start: July 13, 2020
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2026
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Locations

SL (1)