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観察研究プロトコル: LIVER-R (LIVER-R)

2026年10月27日 更新者：AstraZeneca

肝胆道がんにおけるデュルバルマブベースのレジメンの実際の治療結果を評価するための多施設観察研究

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence ).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately 4,000 patients across hepatobiliary cohorts (approximately 1,385 patients for aBTC, approximately 1,165 patients for uHCC, approximately 1,000 patients for eeHCC, and approximately 400 patients for EMERALD) across multiple countries from North and South America, Europe, the Middle East and the Asia-Pacific region. The study design will include primary and secondary data collection. Primary data will be collected in real-time during the patient's routine visit. Secondary data will be collected from the patient's medical record at enrollment and at prespecified study time points (6-month intervals). The study population includes adult patients whose physician has previously made the decision to treat them with or without a durvalumab-based regimen for hepatobiliary cancer as part of routine clinical practice or patients receiving treatment through EAP. The study will include a baseline period of up to 5 years before the index date (initiation of a durvalumab-based or non durvalumab-based regimen) and a follow-up period to the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years. This is a descriptive, noncomparative study. No formal hypotheses are to be tested. All descriptive analyses will be conducted separately for each primary hepatobiliary cancer indication. Kaplan Meier estimates will be produced for time-to-event outcomes.

研究の種類

観察的

入学 (推定)

4000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35233-1932
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      • Mobile、Alabama、アメリカ、36604
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    • Arizona
      • Phoenix、Arizona、アメリカ、85004
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    • California
      • Coronado、California、アメリカ、92118
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      • Los Angeles、California、アメリカ、90048
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      • Walnut Creek、California、アメリカ、94598
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    • Florida
      • Clermont、Florida、アメリカ、34711
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      • Gainesville、Florida、アメリカ、32610
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      • Tampa、Florida、アメリカ、33606
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    • Georgia
      • Augusta、Georgia、アメリカ、30912
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    • Illinois
      • Evergreen Park、Illinois、アメリカ、60805
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      • Hinsdale、Illinois、アメリカ、60521
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    • Louisiana
      • Baton Rouge、Louisiana、アメリカ、70808
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    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
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    • Missouri
      • Osage Beach、Missouri、アメリカ、65065
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    • New York
      • White Plains、New York、アメリカ、10601
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    • Ohio
      • Canton、Ohio、アメリカ、44718
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    • Pennsylvania
      • Bethlehem、Pennsylvania、アメリカ、18015
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      • Lancaster、Pennsylvania、アメリカ、17604
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      • Philadelphia、Pennsylvania、アメリカ、19141
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      • Pittsburgh、Pennsylvania、アメリカ、15212
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    • Texas
      • Dallas、Texas、アメリカ、75390-8567
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      • Temple、Texas、アメリカ、76508
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    • Washington
      • Spokane、Washington、アメリカ、99204
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  • アラブ首長国連邦
    • Abu Dhabi Emirate
      • Mohammed Bin Zayed City、Abu Dhabi Emirate、アラブ首長国連邦、92510
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    • Dubai
      • Deira、Dubai、アラブ首長国連邦、7272
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  • イスラエル
      • Jerusalem、イスラエル、9103102
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      • Tel Aviv、イスラエル、6423906
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    • Northern Didstrict
      • Nahariya、Northern Didstrict、イスラエル、22100
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    • Tel Aviv
      • Ramat Gan、Tel Aviv、イスラエル、52621
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  • イタリア
    • Campania
      • Naples、Campania、イタリア、80131
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    • Lazio
      • Rome、Lazio、イタリア、00128
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      • Rome、Lazio、イタリア、00168
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    • Lombardy
      • Brescia、Lombardy、イタリア、25123
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      • Milan、Lombardy、イタリア、20132
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      • Milan、Lombardy、イタリア、20133
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      • Rozzano、Lombardy、イタリア、20089
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    • Piedmont
      • Turin、Piedmont、イタリア、10126
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    • Sardinia
      • Monserrato、Sardinia、イタリア、09042
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    • Tuscany
      • Pisa、Tuscany、イタリア、56124
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  • オーストラリア
    • Australian Capital Territory
      • Garran、Australian Capital Territory、オーストラリア、2605
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    • Victoria
      • Heidelberg、Victoria、オーストラリア、3084
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      • Melbourne、Victoria、オーストラリア、3004
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    • Western Australia
      • Murdoch、Western Australia、オーストラリア、6150
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  • オーストリア
    • Lower Austria
      • Sankt Pölten、Lower Austria、オーストリア、3100
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    • State of Vienna
      • Vienna、State of Vienna、オーストリア、1090
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    • Upper Austria
      • Linz、Upper Austria、オーストリア、4010
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  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4N2
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      • Edmonton、Alberta、カナダ、T6G-1Z2
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    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 2Y9
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    • Ontario
      • London、Ontario、カナダ、N6A 5W9
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  • ギリシャ
    • Athens
      • Chaïdári、Athens、ギリシャ、12462
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    • Attica
      • Athens、Attica、ギリシャ、11527
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      • Athens、Attica、ギリシャ、14564
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    • Central Macedonia
      • Thessaloniki、Central Macedonia、ギリシャ、55236
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      • Thessaloniki、Central Macedonia、ギリシャ、54639
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    • Thessaly
      • Larissa、Thessaly、ギリシャ、41110
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  • サウジアラビア
    • Ar Riyadh
      • Riyadh、Ar Riyadh、サウジアラビア、12231
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    • Mecca Region
      • Jeddah、Mecca Region、サウジアラビア、22384
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  • シンガポール
      • Singapore、シンガポール、169610
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      • Singapore、シンガポール、329563
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  • スイス
      • Zurich、スイス、8032
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    • Canton of Vaud
      • Lausanne、Canton of Vaud、スイス、1005
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  • スペイン
      • Barcelona、スペイン、8035
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      • Madrid、スペイン、28007
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      • Madrid、スペイン、28034
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      • Madrid、スペイン、28040
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      • Madrid、スペイン、28041
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      • Oviedo、スペイン、33011
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      • Pamplona、スペイン、31008
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      • Santa Cruz de Tenerife、スペイン、38010
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      • Seville、スペイン、41009
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      • Valencia、スペイン、46010
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    • A Coru A
      • Santiago de Compostela、A Coru A、スペイン、15706
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    • Aragon
      • Zaragoza、Aragon、スペイン、50009
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    • C Rdoba
      • Poniente Sur、C Rdoba、スペイン、14004
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    • Cantabria
      • Santander、Cantabria、スペイン、39008
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    • Castile-Le N
      • Burgos、Castile-Le N、スペイン、9006
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    • Galicia
      • Ourense、Galicia、スペイン、32005
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    • Madrid
      • Majadahonda、Madrid、スペイン、28222
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    • Murcia
      • El Palmar、Murcia、スペイン、30120
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  • ドイツ
      • Berlin、ドイツ、13353
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      • Berlin、ドイツ、14165
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      • Bremen、ドイツ、28211
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      • Hamburg、ドイツ、22291
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      • Hamburg、ドイツ、20259
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    • Baden W Rttemberg
      • Heidenheim、Baden W Rttemberg、ドイツ、89522
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    • Baden-W Rttemberg
      • Konstanz、Baden-W Rttemberg、ドイツ、78484
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      • Mannheim、Baden-W Rttemberg、ドイツ、68167
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      • Schorndorf、Baden-W Rttemberg、ドイツ、73614
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      • Stuttgart、Baden-W Rttemberg、ドイツ、70174
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    • Bavaria
      • Augsburg、Bavaria、ドイツ、86150
        • 終了しました
        • Research Site
      • Munich、Bavaria、ドイツ、81377
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    • Free Hanseatic City of Bremen
      • Bremenhaven、Free Hanseatic City of Bremen、ドイツ、27574
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    • Hesse
      • Kassel、Hesse、ドイツ、34125
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      • Marburg、Hesse、ドイツ、35033
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    • Hesse Land
      • Wiesbaden、Hesse Land、ドイツ、65189
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    • Lower Saxony
      • Göttingen、Lower Saxony、ドイツ、37075
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      • Hanover、Lower Saxony、ドイツ、30161
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      • Hanover、Lower Saxony、ドイツ、30459
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    • Mecklenburg-Vorpommern
      • Rostock、Mecklenburg-Vorpommern、ドイツ、18057
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    • North Rhine-Westphalia
      • Aachen、North Rhine-Westphalia、ドイツ、52074
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      • Bochum、North Rhine-Westphalia、ドイツ、44892
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      • Cologne、North Rhine-Westphalia、ドイツ、50937
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      • Dortmund、North Rhine-Westphalia、ドイツ、44137
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      • Moers、North Rhine-Westphalia、ドイツ、47441
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      • Stolberg、North Rhine-Westphalia、ドイツ、52222
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    • Rhineland-Palatinate
      • Koblenz、Rhineland-Palatinate、ドイツ、56073
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    • Saxony
      • Dresden、Saxony、ドイツ、1307
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      • Leipzig、Saxony、ドイツ、4103
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      • Zwickau、Saxony、ドイツ、8060
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    • Saxony-Anhalt
      • Halle、Saxony-Anhalt、ドイツ、06108
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      • Magdeburg、Saxony-Anhalt、ドイツ、39120
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    • Schleswig-Holstein
      • Neumünster、Schleswig-Holstein、ドイツ、24534
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  • ノルウェー
    • Akershus
      • Lorenskog、Akershus、ノルウェー、1478
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    • Hordaland
      • Bergen、Hordaland、ノルウェー、5021
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    • Stlandet
      • Oslo、Stlandet、ノルウェー、379
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  • フランス
    • Alsace
      • Strasbourg、Alsace、フランス、67000
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    • Auvergne-Rh ne-Alpes
      • Grenoble、Auvergne-Rh ne-Alpes、フランス、38700
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    • Brittany Region
      • St-Malo、Brittany Region、フランス、35403
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    • Grand Est
      • Mulhouse、Grand Est、フランス、68100
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    • Hauts-de-France
      • Boulogne-sur-Mer、Hauts-de-France、フランス、62200
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    • New Aquitaine
      • Poitiers、New Aquitaine、フランス、86000
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    • Provence-Alpes-Côte d'Azur Region
      • Avignon、Provence-Alpes-Côte d'Azur Region、フランス、84918
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      • Marseille、Provence-Alpes-Côte d'Azur Region、フランス、13008
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    • Île-de-France Region
      • Paris、Île-de-France Region、フランス、75012
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      • Paris、Île-de-France Region、フランス、75014
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  • ブラジル
      • São Paulo、ブラジル、04538-132
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      • São Paulo、ブラジル、01246-000
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    • Paraná
      • Curitiba、Paraná、ブラジル、81480-580
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    • Recife - PE
      • Recife - PE、Recife - PE、ブラジル、50070-490
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    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、ブラジル、90035-001
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    • São Paulo
      • Morumbi、São Paulo、ブラジル、05651-901
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  • プエルトリコ
    • Rio Piedras
      • San Juan、Rio Piedras、プエルトリコ、00935
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  • ベルギー
    • Anderlecht
      • Brussels、Anderlecht、ベルギー、1070
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    • Antwerp
      • Bonheiden、Antwerp、ベルギー、2820
        • 募集
        • Research Site
      • Edegem、Antwerp、ベルギー、2650
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        • Research Site
    • Brabant
      • Leuven、Brabant、ベルギー、3000
        • 募集
        • Research Site
    • Wallonia
      • Liège、Wallonia、ベルギー、4000
        • 募集
        • Research Site
    • West Flanders
      • Stene、West Flanders、ベルギー、8400
        • 募集
        • Research Site
  • ポルトガル
      • Faro、ポルトガル、8000-386
        • 募集
        • Research Site
      • Lisbon、ポルトガル、1400 - 038
        • 募集
        • Research Site
      • Lisbon、ポルトガル、1649-028
        • 募集
        • Research Site
    • North
      • Vila Real、North、ポルトガル、5000-508
        • 募集
        • Research Site
  • ルーマニア
      • Bucharest、ルーマニア、22328
        • 募集
        • Research Site
      • Cluj-Napoca、ルーマニア、400162
        • 募集
        • Research Site
      • Craiova、ルーマニア、200347
        • 募集
        • Research Site
      • Iași、ルーマニア、700483
        • 募集
        • Research Site
  • 台湾
      • Kaohsiung City、台湾、82445
        • 募集
        • Research Site
      • Taipei、台湾、11217
        • 募集
        • Research Site
      • Taipei、台湾、100225
        • 募集
        • Research Site
      • Taoyuan City、台湾、33305
        • 募集
        • Research Site
    • Taichung City
      • Taichung、Taichung City、台湾、40705
        • 募集
        • Research Site
  • 日本
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、466-8550
        • 募集
        • Research Site
    • Chiba
      • Kashiwa-shi、Chiba、日本、277-8577
        • 募集
        • Research Site
    • Fukuoka
      • Kurume、Fukuoka、日本、830-0011
        • 募集
        • Research Site
    • Ishikawa-ken
      • Kanazawa、Ishikawa-ken、日本、920-8641
        • 募集
        • Research Site
    • Kanagawa
      • Yokohama、Kanagawa、日本、241-8515
        • 募集
        • Research Site
    • Kyoto
      • Kyoto、Kyoto、日本、606-8507
        • 募集
        • Research Site
    • Miyagi
      • Sendai、Miyagi、日本、980-8574
        • 募集
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    • Osaka
      • Ōsaka-sayama、Osaka、日本、589-8511
        • 募集
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～130年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

The study population includes patients treated with durvalumab-based and non durvalumab-based regimens for hepatobiliary cancer as part of routine clinical practice. The decision to treat patients with a durvalumab based regimen should be independent from the decision to enroll patients in the study.

説明

Inclusion Criteria General Inclusion Criteria

All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:

  1. Age ≥18 years and a lawful adult in the country at the index date
  2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)
  3. Decision to treat was made independently and prior to obtaining informed consent
  4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)

aBTC Specific Inclusion Criteria

A patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable aBTC
  2. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

uHCC Specific Inclusion Criteria

A patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable uHCC
  2. Not eligible for LRT, as well as for those who progressed following LRT
  3. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

eeHCC Specific Inclusion Criteria

A patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh A-B7
  3. Disease not amenable to curative treatment but amenable to LRT at index
  4. Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024
  5. Patients eligible for LRT with palliative intent such as TACE/ TARE/transarterial infusion chemotherapy (TAIC)/ hepatic arterial infusion chemotherapy (HAIC)/transarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT

EMERALD Specific Inclusion Criteria

A patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh score of A-B7
  3. Liver-confined disease not amenable to curative treatment but amenable to LRT at index
  4. Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)

Exclusion Criteria

General Exclusion Criteria

A patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:

  1. Currently/was participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date
  2. Second primary malignancy prior to HCC or BTC diagnosis

aBTC Specific Exclusion Criteria

A patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible

uHCC Specific Exclusion Criteria

A patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date

eeHCC Specific Exclusion Criteria

A patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

EMERALD Specific Exclusion Criteria

A patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：OTHER

コホートと介入

グループ/コホート
介入・治療
unresectable hepatocellular carcinoma (uHCC)

advanced uHCC patients who had not received prior systemic therapy and were not eligible for LRT, as well as those who had progressed following LRT, and who have received a durvalumab-based regimen
他の：Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

他の名前：
  • インフィンジ
他の：Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

他の名前：
  • インフィンジ
advanced biliary tract cancer (aBTC)

patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen
他の：Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

他の名前：
  • インフィンジ
他の：Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

他の名前：
  • インフィンジ
eeHCC

uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive LRT alone or LRT followed by systemic therapy within 60 days (if administered in combination, LRT must be received first)
他の：Non Durvalumab-based therapies in observational study setting

Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.
EMERALD

uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive durvalumab-based regimens in combination with LRT (durvalumab and LRT are given within 28 days of each other, regardless of order)
他の：Durvalumab-based combination therapies in observational study settings

Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected

他の名前：
  • インフィンジ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Real-world overall survival (rwOS) in all participants
時間枠：rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years.

rwOS will be calculated as the time from the index date to date of death, by any cause.
rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years.

二次結果の測定

結果測定
メジャーの説明
時間枠
Clinically significant events (CSEs) of interest leading to a medical intervention in all participants
時間枠：CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based or non durvalumab-based regimens or death, whichever occurs first.

CSEs of interest leading to medical intervention including treatment interruption, discontinuation, hospitalization, or which require interventions of concomitant use of corticosteroids, immunosuppressants and/or endocrine therapies will be captured for the enrolled patients.
CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based or non durvalumab-based regimens or death, whichever occurs first.
Patient demographic and clinical characteristics in all participants
時間枠：Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.

Descriptive statistics will be used to describe demographic and clinical characteristics for the enrolled patients.
Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.
Characterize the durvalumab-based regimen and/or LRT treatment patterns in all participants
時間枠：Treatment patterns will be captured from the index date until the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years.

Treatment patterns of the index durvalumab-based regimen or LRT will be described.

Treatment patterns of therapies administered both before and after the first administration of index durvalumab-based regimen or LRT will be described.
Treatment patterns will be captured from the index date until the earliest of death, loss to follow-up, withdrawal, or end of study for a minimum follow-up of 2 years.
Real-world duration of treatment (rwDOT) in all participants
時間枠：rwDOT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median DOT for a minimum follow-up of 2 years.

rwDOT will be calculated as the time from the index date to date of discontinuation of the index durvalumab-based regimen or LRT.
rwDOT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median DOT for a minimum follow-up of 2 years.
Real-world progression free survival (rwPFS) in all participants
時間枠：rwPFS will be assessed as PFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median PFS for a minimum follow-up of 2 years.

rwPFS will be calculated as the time from the index date to the earliest date of documented disease progression as determined by the physician's assessment or death.
rwPFS will be assessed as PFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median PFS for a minimum follow-up of 2 years.
Real-world time to progression (rwTTP) in all participants
時間枠：rwTTP will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTP for a minimum follow up of 2 years.

rwTTP will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment.
rwTTP will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTP for a minimum follow up of 2 years.
Real-world time to next treatment (rwTTNT) in all participants
時間枠：rwTTNT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTNT for a minimum follow-up of 2 years.

rwTTNT will be calculated as the time from the index date (first-line treatment date) to the date of initiation of the next treatment. rwTTNT will also be assessed for subsequent lines of therapy among patients who started a second line of therapy until a third line of therapy, patients who started a third line of therapy until a fourth line of therapy (rwTTNT), etc.
rwTTNT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTNT for a minimum follow-up of 2 years.
Real-world time to treatment discontinuation (rwTTD) in all participants
時間枠：rwTTD will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTD for a minimum follow-up of 2 years.

rwTTD will be calculated as the time from index date until discontinuation of treatment for any reason, including disease progression, toxicity, and death.
rwTTD will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTD for a minimum follow-up of 2 years.
Characterization of providers among all participants
時間枠：Provider characteristics will be captured up to 5 years prior to the index date

Descriptive statistics will be used to describe provider characteristics: academic vs. community.
Provider characteristics will be captured up to 5 years prior to the index date
Real-world recurrence free survival (rwRFS) in aBTC and uHCC
時間枠：rwRFS will be assessed as RFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median RFS for a minimum follow-up of 2 years.

rwRFS will be defined as the time from the index date to the earliest date of documented disease recurrence as determined by the physician's assessment or death, whichever is earlier. The analysis will be performed in patients who underwent curative therapy (resection or ablation).
rwRFS will be assessed as RFS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median RFS for a minimum follow-up of 2 years.
Real-world time to recurrence (rwTTR) in aBTC and uHCC
時間枠：rwTTR will be assessed as recurrence rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTR for a minimum follow-up of 2 years.

rwTTR will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment. The analysis will be performed in patients who underwent curative therapy (resection or ablation).
rwTTR will be assessed as recurrence rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median TTR for a minimum follow-up of 2 years.
Liver function over time in eeHCC and EMERALD
時間枠：Liver function will be assessed as the change in liver function markers for a minimum follow-up of 2 years

Liver function markers over time will be examined including the closest measure to the index date in the baseline period of first LRT, from pre-treatment through the follow-up period. The primary summary of interest is the change (or trajectory) in liver function markers (ALBI score and Child-Pugh score) over time.
Liver function will be assessed as the change in liver function markers for a minimum follow-up of 2 years
Provider specialty and treatment patterns in eeHCC
時間枠：Provider specialty will be assessed descriptively and treatment patterns will be assessed as a percentage of participants for a minimum follow-up of 2 years

Provider specialty characteristics will be described. The percentage of participants receiving LRT as subsequent line of treatment (among participants receiving only LRT as standard of care).
Provider specialty will be assessed descriptively and treatment patterns will be assessed as a percentage of participants for a minimum follow-up of 2 years
Clinical characteristics in EMERALD and eeHCC
時間枠：Clinical characteristics will be assessed descriptively for a minimum follow-up of 2 years.

The percentage of participants who receive subsequent curative resection or liver transplant will be described.
Clinical characteristics will be assessed descriptively for a minimum follow-up of 2 years.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

協力者

ICON plc

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年12月20日

一次修了 (推定)

2030年12月30日

研究の完了 (推定)

2030年12月30日

試験登録日

最初に提出

2023年12月21日

QC基準を満たした最初の提出物

2024年2月1日

最初の投稿 (実際)

2024年2月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月28日

QC基準を満たした最後の更新が送信されました

2026年10月27日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D419CR00035

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Plan to share only the redacted CSR synopsis

IPD 共有時間枠

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共有アクセス基準

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD 共有サポート情報タイプ

  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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