Pancreas CancerPanECTNCT04281290

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

A study testing Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) in people with Pancreas Cancer, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreas Cancer
What is being tested?: Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteSlovenia
Study dates: 13 Jul 2020to 8 May 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

University Medical Centre Ljubljana, Ljubljana, Slovenia
Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer

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.

Read the detailed description

The study will be conducted on patients with resectable pancreatic cancer. 10patients will be included in phase I clinical study and additional 10patients in phase II clinical study (or in the extension of the clinical study).

After surgical resection of pancreatic cancer, the posterior resection surface will be treated with purpose to lower disease recurrence rate. Plate electrodes will be used for ECT treatment, the electrodes will be placed between choledochal cut-end, truncus celiacus, remaining of the pancreas and aortal lymph nodes.

ECT will be performed within 8-28 min after intravenous in bolus administration of bleomycin (15 mg/m2). Triggering of electric pulses will be synchronized with ECG signals, through the ECG triggering device AccuSync to avoid delivery of pulses in vulnerable period of the heart.

All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.

Conditions: Pancreas Cancer
Being tested: Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Keywords: Pancreatic cancer, Electrochemotherapy, Bleomycin
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04281290
Study group	Role	What they receive
Experimental group	Experimental	Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Receives: Procedure: Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days after operation

Secondary outcomes (2)

Disease-free Survival
Disease-free survival is defined as the amount of time a subject survives without disease recurrence after treatment. Recurrence is defined as significant elevation of tumor markers Ca19-9 and CEA after operation (normal value of Ca19-9 is under 37.0 kU/L, normal value of CEA is under 4.2 µg/L). The appearance of one or more lesions on imaging investigation (US and/or CT) is also considered a recurrence.
The tumor markers and imaging investigations will be performed according to study protocol (tumor markers 1, 3, 6, 12 and 24 months after operation; imaging 1, 3, 6, 12, 18 and 24 months after operation - the imaging method will be CT or MR with or without contrast, with the exception of 1 and 18 months after the operation when an US will be performed).
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Overall Survival
Overall survival is defined as the amount of time a subject survives after therapy. Patient enrolled in the study will be followed up for at least five years. During first two years after surgery follow-up will be as written above, after that period patient will be followed-up according every 6 months.
Measured: From the time of surgical treatment until 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 20208 May 2026

First posted24 Feb 2020
Study start13 Jul 2020
Primary completion8 May 2023
Study completion8 May 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreas CancerStudies of the same condition, open and under way.
More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04281290
Sponsor's protocol ID: 21K/01/20
Acronym: PanECT
Status last verified: Mar 2026
First submitted: 14 Jan 2020
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 37748261

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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All Pancreas Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer
ClinicalTrials.gov ID: NCT04281290
Acronym / sponsor ID: PanECT / 21K/01/20
Conditions: Pancreas Cancer
Keywords: Pancreatic cancer, Electrochemotherapy, Bleomycin
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 10 participants (actual)
Lead sponsor: University Medical Centre LjubljanaUniversity, hospital or other
Collaborators: Institute of Oncology Ljubljana
Study start: 13 Jul 2020 (actual)
Primary completion: 8 May 2023 (actual)
Study completion: 8 May 2026 (estimated)
First posted: 24 Feb 2020 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Detailed description

All patients will be treated after the procedure has been thoroughly described to them and have signed informed consent.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)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)	Procedure or surgery	Experimental group

Primary outcome

Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety
Time frame: 7 days after operation
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.

2 secondary outcomes

Disease-free Survival
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Overall Survival
Time frame: From the time of surgical treatment until 5 years after surgery

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	10	3

Primary outcome: Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety

Time frame: 7 days after operation. Count of participants. Unit: Participants

Measure	Experimental Group n = 10
Value	4

Population analysed: All the enrolled patients were included in analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Postoperative complications: 0-30 days after surgery. Long-term adverse events: from 31 days after surgery through 24 months postoperatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group - Intraoperative Electrochemotherapy Following Pancreaticoduodenectomy	1 of 10 (10%)	6 of 10 (60%)	7 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37748261Cebron 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.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Pancreas Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mihajlo Djokic, MD, PhD principal investigator

University Medical Centre Ljubljana, Ljubljana, Slovenia

Blaz Trotovsek, MD, PhD study director

University Medical Centre Ljubljana, Ljubljana, Slovenia

Gregor Sersa, PhD study director

Institute of Oncology, Ljubljana, Slovenia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety (time frame: 7 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.