Clinical trial · Interventional
Electrochemoterapy With Bleomycin for the Treatment of Unresectable Pancreatic Cancer
A Clinical Trial Using Electrochemotherapy With Bleomycin for the Treatment of Non-metastatic Unresectable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistic reasons
Summary
Brief summary (as posted)
Electrochemotherapy is a type of electroporation that allows the delivery of drugs to the cells through the local creation of pores in the cell membrane. The electric pulses can be applied directly to the neoplastic cells, allowing for the local concentration of a possible chemotherapeutic agent administered through the bloodstream. This technique does not use heat nor other thermal energies and it is performed using special needles/electrodes linked to a generator ("porator"). In this study this technique will be applied on unresectable pancreatic cancer, already submitted to neoadjuvant treatment and still unresectable, through laparotomy. Bleomycin will be the chemotherapeutic agent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotherapy with Bleomycin | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- through study completion, 1 year
- description
- Number of adverse events related with electrochemotherapy (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications are distinct in early (during hospitalization) and late (bile duct stenosis) that may appear during follow-up
Secondary outcomes (7)
- measure
- Feasibility
- timeFrame
- through study completion, 1 year
- description
- Number of procedures planned actually performed
- measure
- Tumour response
- timeFrame
- 12 months
- description
- Analysis of effects of electrochemotherapy on tumor using RECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Radiologic confirmation of locally advanced pancreatic cancer by at least contrast enhanced CT of chest and abdomen (with the upper abdomen scanned according to a dedicated 3mm slice multiphase pancreatic tumor protocol), performed maximum 4 weeks prior to the procedure * Cytohistological diagnosis of pancreatic cancer * Age \> 18 and \< 80 * Stable disease after chemotherapy (no tumor progression, no oncomarkers (Carbohydrate Antigen 19-9 \[CA 19-9\] or Carcinoembryonic antigen \[CEA\]) increase * Performance Status 0 sec. ECOG (Eastern Cooperative Oncology Group) * Written informed consent Exclusion Criteria: * Resectable pancreatic cancer as assessed by multidisciplinary meeting * Stage IV disease * Patients receiving fenitoin, phosphofenitoin or living vaccines * Pregnancy * Progressive disease (either dimensional and not only by stage) * \< 18 years old and \> 80
References
Publications (4)
- RESULTGranata V, Fusco R, Piccirillo M, Palaia R, Petrillo A, Lastoria S, Izzo F. Electrochemotherapy in locally advanced pancreatic cancer: Preliminary results. Int J Surg. 2015 Jun;18:230-6. doi: 10.1016/j.ijsu.2015.04.055. Epub 2015 Apr 24. PMID 25917204
- RESULTBimonte S, Leongito M, Granata V, Barbieri A, Del Vecchio V, Falco M, Nasto A, Albino V, Piccirillo M, Palaia R, Amore A, Giacomo Rd, Lastoria S, Setola SV, Fusco R, Petrillo A, Izzo F. Electrochemotherapy in pancreatic adenocarcinoma treatment: pre-clinical and clinical studies. Radiol Oncol. 2016 Feb 16;50(1):14-20. doi: 10.1515/raon-2016-0003. eCollection 2016 Mar 1. PMID 27069445
- RESULTCampana LG, Mocellin S, Basso M, Puccetti O, De Salvo GL, Chiarion-Sileni V, Vecchiato A, Corti L, Rossi CR, Nitti D. Bleomycin-based electrochemotherapy: clinical outcome from a single institution's experience with 52 patients. Ann Surg Oncol. 2009 Jan;16(1):191-9. doi: 10.1245/s10434-008-0204-8. Epub 2008 Nov 6. PMID 18987914
- RESULTGirelli R, Prejano S, Cataldo I, Corbo V, Martini L, Scarpa A, Claudio B. Feasibility and safety of electrochemotherapy (ECT) in the pancreas: a pre-clinical investigation. Radiol Oncol. 2015 Mar 25;49(2):147-54. doi: 10.1515/raon-2015-0013. eCollection 2015 Jun. PMID 26029026