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Clinical trials for 2017-001538-25

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    1 result(s) found for: 2017-001538-25. Displaying page 1 of 1.
    EudraCT Number: 2017-001538-25 Sponsor Protocol Number: AIO-HEP-0117 Start Date*: 2018-03-12
    Sponsor Name:AIO-Studien-gGmbH
    Full Title: A randomized phase II trial of durvalumab and tremelimumab with gemcitabine or gemcitabine and cisplatin compared to gemcitabine and cisplatin in treatment-naïve patients with cholangio- and gallbl...
    Medical condition: advanced, unresectable and/or metastatic cholangio- and gallbladder carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10017617 Gallbladder cancer non-resectable LLT
    20.0 100000004864 10017620 Gallbladder carcinoma LLT
    20.0 100000004864 10025941 Malignant neoplasm of gallbladder and extrahepatic bile ducts LLT
    21.1 100000004864 10025940 Malignant neoplasm of gallbladder LLT
    20.0 100000004864 10007426 Carcinoma of gallbladder LLT
    21.1 100000004864 10017622 Gallbladder carcinoma non-resectable LLT
    21.1 100000004864 10025943 Malignant neoplasm of gallbladder and extrahepatic bile ducts non-resectable LLT
    21.1 100000004864 10077744 Adenocarcinoma of gallbladder metastatic LLT
    21.1 100000004864 10077847 Gallbladder adenocarcinoma metastatic LLT
    20.0 100000004864 10008594 Cholangiocarcinoma non-resectable LLT
    21.1 100000004864 10077846 Cholangiocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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