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    Clinical Trial Results:
    Neoadjuvant CHemoradiotherapy with sequential Ipilimumab and NivOlumab in RECtal cancer (CHINOREC): a prospective randomized, open-label, multicenter, phase II clinical trial

    Summary
    EudraCT number
    		 2019-003865-17
    Trial protocol
    		 AT  
    Global end of trial date
    15 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2025
    First version publication date
    28 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA209-7HJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04124601
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Organizational unit leader, Medical University of Vienna, viszeralchirurgie@meduniwien.ac.at
    Scientific contact
    Organizational unit leader, Medical University of Vienna, viszeralchirurgie@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
    15 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety, tolerability and feasibility of standard neoadjuvant CRT with sequential ipilimumab and nivolumab following surgical resection.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH GCP guidelines, and all applicable regulatory requirements. Written informed consent was obtained from all participants prior to any study procedures. Ethics Committee and regulatory approvals were obtained before trial initiation. Participant confidentiality was maintained in compliance with data protection laws, and safety was monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2020
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    50
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening investigations will be done according to standard routine surgical practice for patients with rectal cancer who need a neoadjuvant CR.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment
    Arm description
    		 Experimental: Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ipilimumab and Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Experimental: Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)

    Arm title
    		 Control
    Arm description
    		 Other: Neoadjuvant Chemoradiotherapy Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Other: Neoadjuvant Chemoradiotherapy Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)

    Number of subjects in period 1
    		Treatment Control
    Started
    50
    30
    Completed
    50
    30

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Experimental: Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)

    Reporting group title
    Control
    Reporting group description
    		 Other: Neoadjuvant Chemoradiotherapy Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)

    Subject analysis set title
    Analysis sets
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Treatment set This analysis set includes all subjects who were randomized to the treatment arm and received neoadjuvant CRT with sequential Ipilimumab and Nivolumab and did not violate the protocol in a way that might affect the evaluation of the effect of the study drugs on the primary objective. Control set This analysis set includes all subjects who were randomized to the control arm and received neoadjuvant CRT and did not violate the protocol in a way that might affect the evaluation of the effect of the study drugs on the primary objective.

    Primary: Primary Outcome

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    End point title
    		 Primary Outcome
    End point description
    Incidence of treatment-emergent adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).
    End point type
    Primary
    End point timeframe
    20 weeks
    End point values
    		 Treatment Control Analysis sets
    Number of subjects analysed
    50
    30
    80
    Units: 1-5
        number (not applicable)
    50
    30
    80
    Statistical analysis title
    		 Primary endpoint analysis
    Statistical analysis description
    Safety and tolerability will be assessed by comparing case numbers for any complication in the treatment arm (n=50) with the calculated 95% upper CI numbers of the calculated percentage of expected numbers of current standard therapy (Table 2). Case numbers in the control arm (n=30) will be used to validate expected numbers from current standard therapy (i.e. will be compared to the corresponding 95% CI lower and upper borders).
    Comparison groups
    Control v Treatment
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05 [1]
    Method
    		 Exact binomial test
    Confidence interval
    Notes
    [1] - Safety and tolerability will be assessed by comparing case numbers for any complication in the treatment arm (n=50) with the calculated 95% upper CI numbers of the calculated percentage of expected numbers of current standard therapy (Table 2).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Adverse event reporting additional description
    The study duration for the individual participant will be approximately 20 weeks: 5 weeks of standard neoadjuvant CRT, following surgery 10 to 12 weeks after, including routine clinical and diagnostic work up of about 3 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Myositis
    Reporting group description
    		 -

    Serious adverse events
    		 Myositis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Myositis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    3 / 50 (6.00%)
         occurrences all number
    3

    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
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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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