Oesophageal CancerVECTORNCT04649372
EndoVE endosCopic Treatment for Oesophageal and Gastric canceR
A study testing EndoVE in people with Oesophageal Cancer and Oesophageal Disease, run by Mirai Medical at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Oesophageal Disease, Gastric Cancer
- What is being tested?
- EndoVE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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,
- Conditions
- Oesophageal Cancer, Oesophageal Disease, Gastric Cancer
- Being tested
- EndoVE
- Keywords
- Palliation
- Medical subject headings
- Esophageal Neoplasms, Esophageal Diseases, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoVEProcedure or surgery
Also called ePORE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: EndoVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (5)
Efficacy of system in palliation of dysphagia
Change in dysphagia post treatment as measured by Ogilvie Dysphagia Score
Measured: 12 weeks
Response Evaluation Criteria in Solid Tumours (RECIST)
Following CT scan at 12 weeks, a response evaluation will be conducted and reported.
Measured: 12 Weeks Post-Treatment
Evaluation of Patient Reported Quality of Life (EORTC QLQ30)
Change in Quality of Life Patient Reported Outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ30
Measured: 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)
Change in Quality of Life Patient Reported Outcomes as measured by disease specific European Organisation for Research and Treatment of Cancer (EORTC) QLQ-OES18
Measured: 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
Change in pain experienced by the patient before and after treatment as measured by Brief Pain Inventory
Measured: Day 0 Pre-treatment, Day 0 Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start13 Jan 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirai Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Simon Parsons, MD, FRCS, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649372
- Sponsor's protocol ID
- CC-20-001(MM-CC-100)
- Acronym
- VECTOR
- Status last verified
- Jan 2021
- First submitted
- 18 Nov 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23601905Forde 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.
PubMed 27042930Falk 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.
PubMed 32010744Egeland 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.
PubMed 29868638
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoVE endosCopic Treatment for Oesophageal and Gastric canceR
- ClinicalTrials.gov ID
- NCT04649372
- Acronym / sponsor ID
- VECTOR / CC-20-001(MM-CC-100)
- Conditions
- Oesophageal Cancer, Oesophageal Disease, Gastric Cancer
- Keywords
- Palliation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mirai MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoVE endosCopic Treatment for Oesophageal and Gastric canceR | Other | Procedure: EndoVEThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| EndoVEAlso: ePOREOn 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. | Procedure or surgery | EndoVE endosCopic Treatment for Oesophageal and Gastric canceR |
Primary outcome
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)
5 secondary outcomes
Efficacy of system in palliation of dysphagia
Time frame: 12 weeks
Response Evaluation Criteria in Solid Tumours (RECIST)
Time frame: 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
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
Evaluation of Pain pre and post-treatment
Time frame: Day 0 Pre-treatment, Day 0 Post-Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 23601905Jahangeer 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.
- Background: PubMed 27042930Forde 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.
- Results publication: PubMed 32010744Falk 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.
- Results publication: PubMed 29868638Egeland 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.
- Individual participant dataSharing planned: No
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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.
Simon Parsons, MD, FRCS principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoVE in people with Oesophageal Cancer and Oesophageal Disease, run by Mirai Medical at 1 site in United Kingdom.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 21 Jul 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Treatment-Emergent Adverse Events (CTCAE) (time frame: 12 weeks). 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 NCT04649372, which also lists 4 linked publications.
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 21 Jul 2022.