NCT04649372

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

July 21, 2022

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

November 18, 2020

Last Update Submit

July 20, 2022

Conditions

Oesophageal CancerOesophageal DiseaseGastric Cancer

Keywords

Palliation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events (CTCAE)

    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)

    12 weeks

Secondary Outcomes (5)

  • Efficacy of system in palliation of dysphagia

    12 weeks

  • Response Evaluation Criteria in Solid Tumours (RECIST)

    12 Weeks Post-Treatment

  • Evaluation of Patient Reported Quality of Life (EORTC QLQ30)

    Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks

  • Evaluation of Patient Reported Quality of Life (EORTC QLQ-OES18)

    Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks

  • Evaluation of Pain pre and post-treatment

    Day 0 Pre-treatment, Day 0 Post-Treatment

Study Arms (1)

EndoVE endosCopic Treatment for Oesophageal and Gastric canceR

OTHER

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.

Procedure: EndoVE

Interventions

EndoVEPROCEDURE

On the day of the procedure, a review of any changes which occurred since the pre-study visit will be conducted. The patient will be placed under general anaesthesia 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.

Also known as: ePORE
EndoVE endosCopic Treatment for Oesophageal and Gastric canceR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospital

Nottingham, United Kingdom

Location

Related Publications (4)

  • Jahangeer 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: 23601905BACKGROUND

  • Forde 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: 27042930BACKGROUND

  • Falk 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: 32010744RESULT

  • Egeland 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: 29868638RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal DiseasesStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Simon Parsons, MD, FRCS

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 2, 2020

Study Start

January 13, 2021

Primary Completion

July 20, 2022

Study Completion

July 20, 2022

Last Updated

July 21, 2022

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)