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    Clinical Trial Results:
    Treatment of peritoneal carcinomatosis with Pressurized IntraPeritoneal Aerosol Chemotherapy - PIPAC-2 trial -

    Summary
    EudraCT number
    		 2016-003394-18
    Trial protocol
    		 DK  
    Global end of trial date
    20 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 May 2023
    First version publication date
    17 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PIPAC2trial
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03287375
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Odense University Hospital
    Sponsor organisation address
    J.B. Winsloews Vej 4, Odense, Denmark, 5000
    Public contact
    Surgical Department A, Odense University Hospital, 45 65411857, ouh.ode.a.pipac@rsyd.dk
    Scientific contact
    Surgical Department A, Odense University Hospital, 45 65411857, ouh.ode.a.pipac@rsyd.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
    16 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To identify if PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) can induce major/complete response (PRGS 1+2), based on repeated peritoneal biopsies, within a series of three PIPAC procedures.
    Protection of trial subjects
    Conducted in accordance with Helsinki Declaration. Approved by the IRB. Monitored by the Good Clinical Practice Unit at Odense University Hospital
    Background therapy
    		 Not relevant
    Evidence for comparator
    		 Not relevant
    Actual start date of recruitment
    01 Sep 2016
    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: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    110
    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)
    60
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited based on decisions at the dedicated multidisciplinary team conference

    Pre-assignment
    Screening details
    		 The study planned to include 137 patients, but ended up with 143 patients. 33 of these were included in an ePIPAC amendment approved by the Ethical Committee (publications attached), and therefore the total number of patients in thie results database is 110. Of these 110, 62 completed all 3 PIPACs and were thus amenable for primary endpoint eval.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Investigational
    Arm description
    		 Patients receiving PIPAC
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intraabdominal use
    Dosage and administration details
    92 mg/m2 in 150 ml dextrose

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intraabdominal use
    Dosage and administration details
    7.5 mg/m2 in 150 ml saline

    Investigational medicinal product name
    Doxorubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intraabdominal use
    Dosage and administration details
    1.5 mg/m2 in 50 ml saline

    Number of subjects in period 1
    		Investigational
    Started
    110
    Completed
    62
    Not completed
    48
         Adverse event, serious fatal
    4
         Physician decision
    44

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 -

    Reporting group values
    		 Study period Total
    Number of subjects
    		 110 110
    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)
    		 60 60
        From 65-84 years
    		 50 50
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 63 (34 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 66 66
        Male
    		 44 44

    End points

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    End points reporting groups
    Reporting group title
    Investigational
    Reporting group description
    		 Patients receiving PIPAC

    Primary: No. patients with histological regression (PRGS 1-2)

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    End point title
    		 No. patients with histological regression (PRGS 1-2) [1]
    End point description
    End point type
    Primary
    End point timeframe
    After 3 PIPACs
    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: This is merely decriptive data including a ratio, no advanced statistics were applied. Please consult the published article for more details.
    End point values
    		 Investigational
    Number of subjects analysed
    62
    Units: no. patients
    110
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first intervention to 30 days after the last PIPAC
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Intervention arm
    Reporting group description
    		 Per procedure (n=336)

    Serious adverse events
    		 Intervention arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 110 (3.64%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 110 (0.91%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Cancer with a high tumour mutational burden
    Additional description: Progressive disease
         subjects affected / exposed
    3 / 110 (2.73%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Intervention arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 110 (17.27%)
    Gastrointestinal disorders
    Pain assessment
    Additional description: Grade 3 or higher
         subjects affected / exposed
    8 / 110 (7.27%)
         occurrences all number
    8
    Constipation
    Additional description: Grade 3 or higher
         subjects affected / exposed
    2 / 110 (1.82%)
         occurrences all number
    2
    Ileus
    Additional description: Grade 3 or higher
         subjects affected / exposed
    6 / 110 (5.45%)
         occurrences all number
    6
    Nausea
    Additional description: Grade 3 or higher
         subjects affected / exposed
    3 / 110 (2.73%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Apr 2018
    Application of one minute of electrostatic precipitation (ePIPAC) in 33 patients. This amendment was approved by the ethics committee, and did not alter the IMPs.

    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.
    The publications are divided in the PIPAC-OPC2 study (n=110) (PMID: 36602663) and the amendment of ePIPAC with one minute of electrostatic precipitation (n=33) (PMID: 31493986)

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36602663
    http://www.ncbi.nlm.nih.gov/pubmed/31493986
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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
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