EndoVE endosCopic Treatment for Oesophageal and Gastric canceR (VECTOR)

July 20, 2022 updated by: Mirai Medical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of electroporation has expanded over the last twenty years since its first clinically reported study in the treatment of head and neck cancer in 1991.

In electroporation short high-voltage pulses are delivered directly to the tumour which transiently permeabilises the cell membranes enabling targeted cell death and also allowing otherwise non-permeant chemotherapeutic drugs to enter the cancer cells. The parameters of a successful electroporation process are determined by the strength of the electric field and the duration of the electrical field exposure. ePORE and EndoVE deliver electroporation parameters which successfully electroporate cells in the reversible electroporation range, whilst eliminating muscular contractions. Both devices are CE marked and will be used within the definition of their intended use.

Currently over 150 sites in Europe are reported to be employing electroporation in the clinical management of head & neck, recurrent breast, malignant melanoma, colorectal, liver metastasis, pancreatic and inoperable glioma. The standard operating procedures for electroporation and electrochemotherapy were established during the EU funded ESOPE study which established the clinical application of electroporation in combination with cisplatin or bleomycin. The EndoVE device has already been used successfully in phase I studies in patients with inoperable oesophageal and colorectal cancer. No serious adverse events were noted with positive tumour regression observed after a single treatment.

A patient recruited to the study will be requested to attend a pre-study visit where informed consent will be obtained before proceeding to review medical history and conduct a full clinical examination, full blood count, EKG and assessment of tumour volume via a CT. The procedure will happen no later than 28 days after the pre-study visit - Day 0.

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 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,

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom
        • Nottingham University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EndoVE endosCopic Treatment for Oesophageal and Gastric canceR
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
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.
Other Names:
  • ePORE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (CTCAE)
Time Frame: 12 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of system in palliation of dysphagia
Time Frame: 12 weeks
Change in dysphagia post treatment as measured by Ogilvie Dysphagia Score
12 weeks
Response Evaluation Criteria in Solid Tumours (RECIST)
Time Frame: 12 Weeks Post-Treatment
Following CT scan at 12 weeks, a response evaluation will be conducted and reported.
12 Weeks Post-Treatment
Evaluation of Patient Reported Quality of Life (EORTC QLQ30)
Time Frame: Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks
Change in Quality of Life Patient Reported Outcomes as measured by European Organisation for Research and Treatment of Cancer (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)
Time Frame: Baseline (Day 0), Day 0 + 2 days, Day 0 + 1 week, Day 0 + 4 Weeks, Day 0 + 8 Weeks, Day 0 + 12 Weeks
Change in Quality of Life Patient Reported Outcomes as measured by disease specific European Organisation for Research and Treatment of Cancer (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
Time Frame: Day 0 Pre-treatment, Day 0 Post-Treatment
Change in pain experienced by the patient before and after treatment as measured by Brief Pain Inventory
Day 0 Pre-treatment, Day 0 Post-Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirai Medical

Collaborators

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Simon Parsons, MD, FRCS, Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-20-001(MM-CC-100)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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