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    Clinical Trial Results:
    Chemotherapy with gemcitabine, capecitabine, irinotecan and bevacizumab to patients with cholangiocarcinoma after progression on first line treatment.

    Summary
    EudraCT number
    		 2013-001559-11
    Trial protocol
    		 DK  
    Global end of trial date
    01 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1312
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Oncology Department, Herlev University Hospital, 45 36682329, Ole.larsen@regionh.dk
    Scientific contact
    Oncology Department, Herlev University Hospital, 45 36682329, Ole.larsen@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 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary endpoint Progression free survival
    Protection of trial subjects
    Standard Safety Monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2013
    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: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    23
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was open from Nov 2013 til Jan 2016, all patients recruited at single site (Herlev University Hospital)

    Pre-assignment
    Screening details
    		 Patients with biliary tract cancer with progression from 1st-line treatment.

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

    Arms
    Arm title
    		 Trial Treatment
    Arm description
    		 Capecitabine, Gemcitabine, Irinotecan and Bevacizumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    650 mg/m2 twice a day, continuously

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 every 2nd week

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    110 mg/m2 every 2nd week

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/kg every 2nd week

    Number of subjects in period 1
    		Trial Treatment
    Started
    48
    Completed
    37
    Not completed
    11
         Lack of efficacy
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 48 48
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (34 to 83) -
    Gender categorical
    Units: Subjects
        Female
    		 26 26
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    Trial Treatment
    Reporting group description
    		 Capecitabine, Gemcitabine, Irinotecan and Bevacizumab

    Primary: Progression free survival

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    End point title
    		 Progression free survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    Time from treatment start to progression or death
    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: Single arm phase II trial
    End point values
    		 Trial Treatment
    Number of subjects analysed
    48
    Units: months
        median (confidence interval 95%)
    3.6 (3.0 to 4.2)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Time from treatment start to death (censoring at time of analysis)
    End point values
    		 Trial Treatment
    Number of subjects analysed
    48
    Units: months
        median (confidence interval 95%)
    6.4 (3.8 to 8.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    treatment start to progression
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    3.1
    Reporting groups
    Reporting group title
    Trial Treatment
    Reporting group description
    		 Capecitabine, Gemcitabine, Irinotecan and Bevacizumab

    Serious adverse events
    		 Trial Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 48 (39.58%)
         number of deaths (all causes)
    45
         number of deaths resulting from adverse events
    2
    Injury, poisoning and procedural complications
    Contrast fluid in abdomen
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    arterial fibriliation
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    transient cerebral ischemia
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ascites
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    10 / 48 (20.83%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Trial Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 48 (100.00%)
    Investigations
    Thrombocytopenia
         subjects affected / exposed
    7 / 48 (14.58%)
         occurrences all number
    7
    Neutropenia
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences all number
    4
    liver enzymes increased
         subjects affected / exposed
    6 / 48 (12.50%)
         occurrences all number
    6
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    12 / 48 (25.00%)
         occurrences all number
    12
    Thromboembolic event
         subjects affected / exposed
    6 / 48 (12.50%)
         occurrences all number
    6
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    30 / 48 (62.50%)
         occurrences all number
    30
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 48 (10.42%)
         occurrences all number
    5
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    36 / 48 (75.00%)
         occurrences all number
    36
    Vomiting
         subjects affected / exposed
    15 / 48 (31.25%)
         occurrences all number
    15
    Diarrhoea
         subjects affected / exposed
    20 / 48 (41.67%)
         occurrences all number
    20
    Stomatitis
         subjects affected / exposed
    21 / 48 (43.75%)
         occurrences all number
    21
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 48 (16.67%)
         occurrences all number
    8
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    4 / 48 (8.33%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    20 / 48 (41.67%)
         occurrences all number
    20

    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/28930749
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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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