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    Clinical Trial Results:
    Endoscopic assisted Calcium electroporation in esophageal cancer – a safety study

    Summary
    EudraCT number
    		 2020-005787-58
    Trial protocol
    		 DK  
    Global end of trial date
    04 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Oct 2023
    First version publication date
    05 Oct 2023
    Other versions
    Summary report(s)
    		 Published manuscript

    Trial information

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    Trial identification
    Sponsor protocol code
    eCaEP2021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Michael Achiam
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Charlotte Egeland, Charlotte Egeland, +45 20855881, charlotte.karin.linnea.egeland.02@regionh.dk
    Scientific contact
    Charlotte Egeland, Charlotte Egeland, +45 20855881, charlotte.karin.linnea.egeland.02@regionh.dk
    Sponsor organisation name
    Michael Achiam
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Michael Achiam, Dept. of Surgery and Transplantation, Rigshospitalet, Copenhagen University Hospital, +45 34450441, michael.patrick.achiam.01@regionh.dk
    Scientific contact
    Michael Achiam, Dept. of Surgery and Transplantation, Rigshospitalet, Copenhagen University Hospital, +45 35450441, michael.patrick.achiam.01@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated.
    Protection of trial subjects
    Pain killers, medicine if side effects. Clinical out patient visits.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period: 1st of June 2021 - 7th of March 2022

    Pre-assignment
    Screening details
    		 16 patients were screend for inclusion of whom 10 were included. 8 of these 10 patients were treated.

    Period 1
    Period 1 title
    Over all trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Calcium electroporation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    0.23 mmol/mL, max 20 mL

    Number of subjects in period 1
    		Treatment
    Started
    10
    Completed
    8
    Not completed
    2
         Physician decision
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Over all trial
    Reporting group description
    		 10

    Reporting group values
    		 Over all trial Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        55-75
    		 7 7
        >75
    		 3 3
    Gender categorical
    sex
    Units: Subjects
        female
    		 2 2
        male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Calcium electroporation

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    In five out of nine procedures, no adverse events were reported within the first 14 days. Two patients reported mild retrosternal pain (grade 1) the first days after treatment, one patient reported worsening anemia (grade 3), and one patient developed oral thrush (grade 2). Out of these events, one was considered a serious adverse event (one-day hospitalization due to anemia, requiring a single blood transfusion).
    End point type
    Primary
    End point timeframe
    14 days after treatment.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since it was only eight patients, only descriptive statistics was used.
    End point values
    		 Treatment
    Number of subjects analysed
    8
    Units: patients
        number (not applicable)
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From treatment and 14 days after treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Calcium electroporation

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Worsening of anaemia, bleeding.
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 8 (37.50%)
    Gastrointestinal disorders
    Retrosternal pain (local pain close to tumor)
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Infections and infestations
    Oral thrush
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36358702
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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