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    Clinical Trial Results:
    PHASE II INVESTIGATION OF CALCIUM ELECTROPORATION AS A TREATMENT FOR CUTANEOUS AND SUBCUTANEOUS MALIGNANT TUMOURS

    Summary
    EudraCT number
    		 2019-004314-34
    Trial protocol
    		 DK   DE  
    Global end of trial date
    04 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2024
    First version publication date
    03 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CaEP-R
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04225767
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Ringstedgade 61, Næstved, Denmark,
    Public contact
    Lars Munch Larsen, Region Zealand, laml@regionsjaelland.dk
    Scientific contact
    Julie Gehl, Region Zealand, kgeh@regionsjaelland.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
    04 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary endpoint of this study is to evaluate the clinical overall response rate of calcium electroporation treatment of malignant tumours of the skin after two months. The evaluation will use the modified RECIST criteria, clinical examination with calliper measurement and photographical documentation using adhesive rulers for scale. Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions.
    Protection of trial subjects
    Patients included had consented in writing and fulfilled all eligibility criteria. Standard safety monitoring was performed during treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Feb 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 17
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    12
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from three sites: Næstved (Denmark), Vejle (Denmark) and Lubeck (Germany).

    Pre-assignment
    Screening details
    		 Patients with any solid cancer and cutaneous metastases could be screened for inclusion. Patients could recieve other treatment, and could be included if there was no sign of regression of the cutaneous metastases - or progression.

    Period 1
    Period 1 title
    inclusion, treatment and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Patients treated with intervention (Calcium electroporation)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Calcium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    Tumors were measured (a longest diameter, b diameter perpendicular to a). A 3 mm margin was added. Calcium chloride was mixed to 220 mM (mixed with sodium chloride). a. Tumour with a diameter <0.5 cm: 1 ml of calcium chloride solution pr cm3 tumour tissue was injected. b. Tumour with a diameter from 0.5 cm to 3 cm: 0.5 ml of calcium chloride solution pr cm3 tumour tissue was injected. (Maximum volume is 20 ml 220 mmol/l calcium chloride.)

    Number of subjects in period 1
    		Experimental
    Started
    19
    Completed
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    inclusion, treatment and follow-up
    Reporting group description
    		 -

    Reporting group values
    		 inclusion, treatment and follow-up Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 6 6
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 6 6

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Patients treated with intervention (Calcium electroporation)

    Primary: Response at two months post treatment

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    End point title
    		 Response at two months post treatment [1]
    End point description
    This EudraCT platform do not allow description at tumor level thus this has to be described in writing here. At the patient level (intention to treat) 6 of 19 patients experienced response at two months. Measuring according to tumors treated (58 tumors) the overall response rate was 36 % at the two months point.
    End point type
    Primary
    End point timeframe
    Two months post 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: In this study percent of responding lesions (descriptive statistics) were used in the primary endpoint. 58 lesions were treated in 19 patients. Please see final publication.
    End point values
    		 Experimental
    Number of subjects analysed
    19
    Units: patients
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study time period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Patients treated with intervention (Calcium electroporation). As non-serious adverse events is not an endpoint the numbers are those who experiencen AE's at two months which are mentioned in the article: "Calcium electroporation in cutaneus metastases - A non-randomised phase II multicentre clinical trial"

    Serious adverse events
    		 Experimental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 19 (10.53%)
         number of deaths (all causes)
    9
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
    Additional description: Patient had concomitant immunotherapy for lung cancer. Treatment area was inspected and there was no sign of infection. SAE deemed not related to therapy.
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
    Additional description: 11 months after treatment the patient get an infection in the tip of the Port-รก-Cath (intravenous catheter). This was deemed not related to treatment.
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Experimental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 19 (15.79%)
    Skin and subcutaneous tissue disorders
    Suppuration
    Additional description: Discharge from cutaneuos metastases
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Ulceration
    Additional description: Ulcerated cutaneuos metastases/ulceration in treated areas
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Pain cutaneous metastases
    Additional description: Pain related to cutaneous metastases/treatment area
         subjects affected / exposed
    1 / 19 (5.26%)
         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/37268521
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