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    Clinical Trial Results:
    REgorafenib’s Liquid BiopsY (RELY): A multicenter translational biomarker phase II trial of regorafenib in patients with non-resectable pretreated colorectal cancer. a non-profit investigator-initiated trial

    Summary
    EudraCT number
    		 2014-004927-27
    Trial protocol
    		 AT  
    Global end of trial date
    01 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2025
    First version publication date
    11 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RELAIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01983098
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedUniWien
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Marika Rosner, MedUniWien, +43 14040044450, marika.rosner@meduniwien.ac.at
    Scientific contact
    Gerlad Prager, MedUniWien, +43 14040044450, gerald.prager@meduniwien.ac.at
    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 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate circulating tumor DNA (ctDNA) via deep sequencing for mutation detection and by whole genome sequencing for copy number analyses before start (baseline) with regorafenib and at defined time points during administration of regorafenib for treatment efficacy in colorectal cancer patients in terms of overall survival (OS).
    Protection of trial subjects
    CT Thorax/Abdomen every 8 weeks
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jan 2015
    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
    Austria: 29
    Country: Number of subjects enrolled
    Switzerland: 1
    Worldwide total number of subjects
    30
    EEA total number of subjects
    29
    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)
    20
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 30 patient were enrolled in the trial - 25 in Vienna, 1 in Graz, 1 in Wels and 1 in Zurich.

    Pre-assignment
    Screening details
    		 30 patient were screened according to the inclusion and exclusion criteria

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

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 single-arm study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Regorafenib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Regorafenib in standard dose -160 mg od po, 3 weeks on/1 week off

    Number of subjects in period 1
    		Treatment arm
    Started
    30
    Completed
    30

    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
    		 30 30
    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)
    		 18 18
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60 (33 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 20 20
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Examination of the freely circulating tumor DNA (ctDNA) for mutations using deep sequencing and to determine the number of DNA copies using whole genome sequencing.

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    30
    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)
    18
        From 65-84 years
    12
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    60 (33 to 78)
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    20

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 single-arm study

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Examination of the freely circulating tumor DNA (ctDNA) for mutations using deep sequencing and to determine the number of DNA copies using whole genome sequencing.

    Primary: ctDNA via deep sequencing for mutation detection

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    End point title
    		 ctDNA via deep sequencing for mutation detection
    End point description
    Real time tumor-tissue biopsy will (mandatory) be performed at baseline (within 4 weeks before start with regorafenib) and after 8 weeks (optional). Tumor tissue samples will be analyzed by deep sequencing and whole genome sequencing and results will be correlated to the liquid biopsy analysis and treatment efficacy parameters (see above). In addition, the baseline Immunoscore will be assessed and correlated to treatment efficacy.
    End point type
    Primary
    End point timeframe
    within 4 weeks before , after 4 weeks and after 8 weeks start with regorafenib
    End point values
    		 Treatment arm Overall trial
    Number of subjects analysed
    30
    30
    Units: ctDNA
        median (full range (min-max))
    60 (33 to 78)
    60 (33 to 78)
    Statistical analysis title
    		 ctDNA for mutation detection
    Comparison groups
    Treatment arm v Overall trial
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 no p-value definied
    Parameter type
    		 Cox proportional hazard
    Confidence interval
    Notes
    [1] - Univariate and multivariate semi parametric Cox models
    [2] - no p-value definied

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    There are no records relating to AES
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no records relating to AES

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jun 2015
    For legal reasons, the short title of the study was changed from CRC-RELY to RELAIS
    13 Oct 2015
    Switzerland was added with 1 site

    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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