Esophageal CancerPhase 1NCT04958044
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer
A Phase 1 study testing Calcium Gluconate in people with Esophageal Cancer, run by Michael Patrick Achiam at 1 site in Denmark.
Trial summary
In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Calcium Gluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 25 May 2021to 13 Jun 2022
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years old.
- Histological verified malignant tumor in the esophagus.
- Subjects must have been considered unsuitable for potential curative treatment.
- Locally progressive disease, and other standard oncological treatment have been administrated and/or considered first.
- Performance status ECOG/WHO < 2.
- Expected survival > 3 months.
Show all 10Show fewer
- Platelets ≥ 50 billion/l, International Normalized Ratio (INR) < 1,5.
- Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
- Women of childbearing potential (WOCBP) and male partners to WOCBP should use adequate contraception during the trial.
- Subjects must give written informed consent.
Who cannot join
- Coagulation disorder that cannot be corrected.
- Subjects with a clinically significant cardiac arrhythmia.
- Pregnancy or lactation.
- Concurrent treatment with another investigational medicinal product.
- Stenosis that prevents passage of the endoscope with the device attached.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study
In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis.
It is hypothesized that:
- Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
- CaEP debulks the tumor, facilitating the patient's ability to eat and drink
In this single-arm pilot study, eight patients will be treated.
Read the detailed description
Electroporation facilitates the transport of molecules across the cell membrane and into the cell by means of electrical pulses. An electric field applied to the cell destabilizes the cell membrane forming cracks, which reseals after a few minutes. During this time slot, molecules which normally are impermeable to the cell membrane are able to cross into the cytosol of the cell. Within the last ten years, studies have shown that the combination of intratumoral injection of calcium and electroporation (Calcium electroporation/CaEP) is an effective method in killing cancer cells. CaEP has been evaluated in clinical studies in colorectal cancer, carcinomas in the head and neck area, and in cutaneous metastases with promising results.
In this single-arm pilot study, eight patients with non-curable esophageal cancer will be included.
It is hypothesized that:
- Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
- CaEP debulks the tumor, facilitating the patient's ability to eat and drink
- CaEP induces a systemic immunological response
The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated.
Secondary outcomes include:
- dysphagia (Mellow Pinkas dysphagia score)
- pain (Numeric Rating Scale, NRS)
- quality of life (QoL) (EORTC QLQ-C30)
- tumor response evaluated from computed tomography (CT) and upper endoscopy
- immunologic response
Tertiary outcomes include:
✓ 90-days survival
Participants are initially treated once according to protocol. If well-tolerated, the treatment can be repeated.
- Conditions
- Esophageal Cancer
- Being tested
- Calcium Gluconate
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
Calcium electroporation
| Study group | Role | What they receive |
|---|---|---|
| Calcium electroporation | Experimental | Calcium gluconate 0.23 mmol/ml Maxium dosage 20 ml Intra tumoral injection Receives: Drug: Calcium Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.
Measured: 14 days after treatment
Secondary outcomes (4)
Dysphagia
According to Mellow Pinkas dysphgia scale
Measured: After 7 days, 2-4 weeks and after 6-8 weeks.
Pain
Assesed by Numerical Rating Scale
Measured: After 7 days, 2-4 weeks and after 6-8 weeks.
Qualitiy of life
Assesed by "EORTC QLQ-C30"
Measured: After 7 days, 2-4 weeks and after 6-8 weeks.
90 days survival
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start25 May 2021
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Patrick Achiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Patrick Achiam, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958044
- Sponsor's protocol ID
- eCaEP2021
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Egeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283.
PubMed 36358702
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study
- ClinicalTrials.gov ID
- NCT04958044
- Acronym / sponsor ID
- eCaEP2021
- Conditions
- Esophageal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Michael Patrick AchiamUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 12 Jul 2021 (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.
In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis.
It is hypothesized that:
- Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
- CaEP debulks the tumor, facilitating the patient's ability to eat and drink
In this single-arm pilot study, eight patients will be treated.
Detailed description
Electroporation facilitates the transport of molecules across the cell membrane and into the cell by means of electrical pulses. An electric field applied to the cell destabilizes the cell membrane forming cracks, which reseals after a few minutes. During this time slot, molecules which normally are impermeable to the cell membrane are able to cross into the cytosol of the cell. Within the last ten years, studies have shown that the combination of intratumoral injection of calcium and electroporation (Calcium electroporation/CaEP) is an effective method in killing cancer cells. CaEP has been evaluated in clinical studies in colorectal cancer, carcinomas in the head and neck area, and in cutaneous metastases with promising results.
In this single-arm pilot study, eight patients with non-curable esophageal cancer will be included.
It is hypothesized that:
- Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
- CaEP debulks the tumor, facilitating the patient's ability to eat and drink
- CaEP induces a systemic immunological response
The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated.
Secondary outcomes include:
- dysphagia (Mellow Pinkas dysphagia score)
- pain (Numeric Rating Scale, NRS)
- quality of life (QoL) (EORTC QLQ-C30)
- tumor response evaluated from computed tomography (CT) and upper endoscopy
- immunologic response
Tertiary outcomes include:
✓ 90-days survival
Participants are initially treated once according to protocol. If well-tolerated, the treatment can be repeated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium electroporation | Experimental | Drug: Calcium GluconateCalcium gluconate 0.23 mmol/ml Maxium dosage 20 ml Intra tumoral injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥18 years old.
- Histological verified malignant tumor in the esophagus.
- Subjects must have been considered unsuitable for potential curative treatment.
- Locally progressive disease, and other standard oncological treatment have been administrated and/or considered first.
- Performance status ECOG/WHO < 2.
Key exclusion criteria (6 listed)
- Coagulation disorder that cannot be corrected.
- Subjects with a clinically significant cardiac arrhythmia.
- Pregnancy or lactation.
- Concurrent treatment with another investigational medicinal product.
- Stenosis that prevents passage of the endoscope with the device attached.
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 |
|---|---|---|
| Calcium GluconateCalcium electroporation | Drug | Calcium electroporation |
Primary outcome
Safety
Time frame: 14 days after treatment
Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.
4 secondary outcomes
Dysphagia
Time frame: After 7 days, 2-4 weeks and after 6-8 weeks.
Pain
Time frame: After 7 days, 2-4 weeks and after 6-8 weeks.
Qualitiy of life
Time frame: After 7 days, 2-4 weeks and after 6-8 weeks.
90 days survival
Time frame: 90 days
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 26 Oct 2022.
- Derived from this study: PubMed 36358702Egeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium Gluconate in people with Esophageal Cancer, run by Michael Patrick Achiam at 1 site in Denmark.
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 10 inclusion and 6 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 26 Oct 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 14 days after treatment). 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 NCT04958044, which also lists 1 linked publication.
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 26 Oct 2022.