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    Clinical Trial Results:
    Endoscopic electrochemotherapy in esophageal cancer – a phase II clinical trial

    Summary
    EudraCT number
    		 2020-002878-27
    Trial protocol
    		 DK  
    Global end of trial date
    23 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2023
    First version publication date
    27 Nov 2023
    Other versions
    Summary report(s)
    		 Published paper

    Trial information

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    Trial identification
    Sponsor protocol code
    EECT2020
    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
    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
    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
    01 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Investigating if a single treatment with electrochemotherapy debulks an esophageal tumors, thereby facilitating the patients’ ability to eat and drink, and also prolongs the interval before definitive stenting is required. Further investigate weather the effect lasts longer than the effect from argon plasma coagulation.
    Protection of trial subjects
    n/a
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    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)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with newly diagnosed esophageal cancer, not candidates for potentially curative treatment, could be enrolled in the trial.

    Pre-assignment
    Screening details
    		 All patients referred to the hospital with non-curable esophageal cancer were screened for inclusion.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Electrochemtherapy
    Arm description
    		 Electrochemtherapy with bleomycin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Bleomycin, Baxter A/S 15.000 IU/m2 body surface area

    Arm title
    		 Argon Plasma Coagulation
    Arm description
    		 Argon Plasma Coagulation
    Arm type
    		 Intervention, no drug

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Electrochemtherapy Argon Plasma Coagulation
    Started
    5
    5
    Completed
    5
    4
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Electrochemtherapy
    Reporting group description
    		 Electrochemtherapy with bleomycin

    Reporting group title
    Argon Plasma Coagulation
    Reporting group description
    		 Argon Plasma Coagulation

    Primary: Interventional Treatment Demanding Dysphgia

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    End point title
    		 Interventional Treatment Demanding Dysphgia [1]
    End point description
    End point type
    Primary
    End point timeframe
    Remaining lifetime or at least 1 year.
    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: No statistical comparisons were made due to the low patient number.
    End point values
    		 Electrochemtherapy Argon Plasma Coagulation
    Number of subjects analysed
    5
    4
    Units: 2
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 days after treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    Electrochemtherapy
    Reporting group description
    		 Electrochemtherapy with bleomycin

    Reporting group title
    Argon Plasma Coagulation
    Reporting group description
    		 Argon Plasma Coagulation

    Serious adverse events
    		 Electrochemtherapy Argon Plasma Coagulation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Dehydration/hyperkaliemia
    Additional description: One patient was re-admitted shortly after treatment with ECT due to dehydration and hyperkalemia.
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Electrochemtherapy Argon Plasma Coagulation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    General disorders and administration site conditions
    Syncope
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0

    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
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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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