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    Clinical Trial Results:
    Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma

    Summary
    EudraCT number
    		 2008-007795-23
    Trial protocol
    		 ES  
    Global end of trial date
    23 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2022
    First version publication date
    27 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CD-2009-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01348256
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clinica Universidad de Navarra
    Sponsor organisation address
    AVENIDA PÍO XII, Nº 36, PAMPLONA/IRUÑA, Spain, 31008
    Public contact
    UCEC, Clínica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clínica Universidad de Navarra, 34 948 255 400, ucicec@unav.es
    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
    30 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Progression Free survival
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Nov 2010
    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
    Spain: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 15 patients of 18 and older were randomized. 8 in DC vaccine group and 7 at Observation group.

    Pre-assignment
    Screening details
    		 The original number patients could not be achieved due budget restrictions that forced an early termination of recruitment, when only 19 patients had signed informed consent. Three of the patients were excluded for evaluation due to positive resection margins following neoadjuvant chemotherapy and surgery and one patient withdrew informed consent.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 No Intervention: Observation
    Arm description
    		 Observation after standard treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Experimental: Dendritic cells vaccine
    Arm description
    		 Adjuvant treatment with dendritic cells vaccine after standard treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dendritic cells vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Mature dendritic cells pulsed with autologous tumor lysate were administered intradermally in two or three series (depending on cell availability) of 4 injections (1 per day), spaced 21 to 44 days apart. The expected dose of dendritic cells was 5,000,000, resuspended in 1-2 ml of physiological saline.

    Number of subjects in period 1
    		No Intervention: Observation Experimental: Dendritic cells vaccine
    Started
    7
    8
    Completed
    7
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period.
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period. Total
    Number of subjects
    		 15 15
    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)
    		 11 11
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    No Intervention: Observation
    Reporting group description
    		 Observation after standard treatment.

    Reporting group title
    Experimental: Dendritic cells vaccine
    Reporting group description
    		 Adjuvant treatment with dendritic cells vaccine after standard treatment.

    Primary: Disease Free Survival

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    End point title
    		 Disease Free Survival [1]
    End point description
    End point type
    Primary
    End point timeframe
    Follow-up was performed every 12 weeks (range 11– 14 weeks) ever since surgical treatment by contrast abdominal CT scans.
    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: Survival curves were compared based on the Kaplan Meier estimates. A log rank test was used in order to calculate the difference between curves. All calculations were performed with STATA v.14 statistical package (StataCorp 2015). * 99999=N.R. (Intervention group: Superior limit of 95% C.I . was N.R.)
    End point values
    		 No Intervention: Observation Experimental: Dendritic cells vaccine
    Number of subjects analysed
    7
    8
    Units: month
        median (confidence interval 95%)
    9.53 (5.32 to 18.88)
    25.26 (8.74 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From patient recruitment to trial exit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    No Intervention: Observation
    Reporting group description
    		 -

    Reporting group title
    Experimental: Dendritic cells vaccine
    Reporting group description
    		 -

    Serious adverse events
    		 No Intervention: Observation Experimental: Dendritic cells vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 7 (28.57%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Hepatectomy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 No Intervention: Observation Experimental: Dendritic cells vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    5 / 8 (62.50%)
    Injury, poisoning and procedural complications
    Wound complication
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2
    Paraesthesia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    3
    0
    Decreased appetite
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Induration
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 8 (37.50%)
         occurrences all number
    0
    6
    Mucosal inflammation
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    4
    1
    Injection site rash
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Xerosis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    4
    1
    Dysgeusia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Abdominal discomfort
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Aphonia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 8 (25.00%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 8 (12.50%)
         occurrences all number
    3
    1
    Skin ulcer
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Nail disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    Paronychia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jun 2010
    Modifications in protocol and HIP.
    15 Apr 2011
    Reduction in the number of patients.
    16 Oct 2012
    Sponsor change.
    01 Jan 2013
    Leaving from CAIBER.
    05 Jul 2013
    Modification of IMPD.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Jul 2018
    Temporary halt in recruitment due to lack of funding while new sources of funding were sought to continue recruiting.
    -

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