Clinical trial · Interventional
EndoVE endosCopic Treatment for Oesophageal and Gastric canceR
NCT04649372CI-TRIAL-00059786VECTORcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project aims to establish the safety and efficacy of treating patients with inoperable oesophageal cancer or gastric cancer, using an endoscopic electroporation system (EndoVE) to facilitate direct chemotherapy tumour absorption.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Oesophageal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoVE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- EndoVE endosCopic Treatment for Oesophageal and Gastric canceR
- description
- The patient will be placed under General Anaesthetic or sedated before Bleomycin will be delivered intravenously. The patient will then be treated endoscopically with the EndoVE device. The EndoVE procedure should take no longer than 30 minutes. The patient will then be transferred to the step-down ward to monitor for any adverse events before being discharged. There will be a telephone follow up after 2 days, 7 days, 4 weeks and 8 weeks. The patient will be requested to attend the clinic for a 12-week follow up for clinical review.
- interventionNames
- Procedure: EndoVE
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events (CTCAE)
- timeFrame
- 12 weeks
- description
- Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. The investigation will be put on hold if unacceptable safety issues are outstanding. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated and graded according to Common Terminology Criteria for Adverse Events (CTCAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified oesophageal tumour * Men or women aged at least 18 years of age. * Patient has already received or been considered for surgery, and / or chemo-radiation. * Performance status (Karnofsky \> 60% or ECOG/WHO \<2). * Treatment free interval of at least 2 weeks after previously applied therapy. * Patients must be mentally capable of understanding the information given. * Patients must give written informed consent. Exclusion Criteria: * Coagulation disorder. * Patients with a clinically manifested arrhythmia or with a pacemaker. * Patients with oesophageal stenosis that cannot be relieved via balloon dilation. * Oesophageal tumour treated with radiotherapy in the previous 4 weeks. * Patients with epilepsy. * Pregnancy or lactation/breastfeeding. * Patients known to be Hepatitis B/C or HIV positive. * Concurrent treatment with an investigational medicinal product or participation in another clinical study. * Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. * Highly ulcerated oesophageal tissue. * Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease. * Allergic reactions to bleomycin observed previously * If a bleomycin cumulative dose of 400 x103 IU has been exceeded
References
Publications (4)
- BACKGROUNDJahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17. PMID 23601905
- BACKGROUNDForde PF, Sadadcharam M, Bourke MG, Conway TA, Guerin SR, de Kruijf M, O'Sullivan GC, Impellizeri J, Clover AJP, Soden DM. Preclinical evaluation of an endoscopic electroporation system. Endoscopy. 2016 May;48(5):477-483. doi: 10.1055/s-0042-101343. Epub 2016 Apr 4. PMID 27042930
- RESULTFalk Hansen H, Bourke M, Stigaard T, Clover J, Buckley M, O'Riordain M, Winter DC, Hjorth Johannesen H, Hansen RH, Heeboll H, Forde P, Jakobsen HL, Larsen O, Rosenberg J, Soden D, Gehl J. Electrochemotherapy for colorectal cancer using endoscopic electroporation: a phase 1 clinical study. Endosc Int Open. 2020 Feb;8(2):E124-E132. doi: 10.1055/a-1027-6735. Epub 2020 Jan 22. PMID 32010744
- RESULTEgeland C, Baeksgaard L, Johannesen HH, Lofgren J, Plaschke CC, Svendsen LB, Gehl J, Achiam MP. Endoscopic electrochemotherapy for esophageal cancer: a phase I clinical study. Endosc Int Open. 2018 Jun;6(6):E727-E734. doi: 10.1055/a-0590-4053. Epub 2018 May 25. PMID 29868638