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Протокол наблюдательного исследования: ПЕЧЕНЬ-R (LIVER-R)

27 октября 2026 г. обновлено: AstraZeneca

Наблюдательное многоцентровое исследование для оценки реальных результатов лечения схем на основе дурвалумаба при раке гепатобилиарной системы

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 ).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

4000

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 130 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Наблюдательные модели: COHORT
  • Временные перспективы: OTHER

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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
Другой: 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).

Другие имена:
  • Имфинзи
Другой: 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.

Другие имена:
  • Имфинзи
advanced biliary tract cancer (aBTC)

patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen
Другой: 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).

Другие имена:
  • Имфинзи
Другой: 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.

Другие имена:
  • Имфинзи
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)
Другой: 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)
Другой: Durvalumab-based combination therapies in observational study settings

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

Другие имена:
  • Имфинзи

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Real-world overall survival (rwOS) in all participants
Временное ограничение: 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.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Clinically significant events (CSEs) of interest leading to a medical intervention in all participants
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

AstraZeneca

Соавторы

ICON plc

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

20 декабря 2023 г.

Первичное завершение (Оцененный)

30 декабря 2030 г.

Завершение исследования (Оцененный)

30 декабря 2030 г.

Даты регистрации исследования

Первый отправленный

21 декабря 2023 г.

Впервые представлено, что соответствует критериям контроля качества

1 февраля 2024 г.

Первый опубликованный (Действительный)

12 февраля 2024 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • D419CR00035

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Plan to share only the redacted CSR synopsis

Сроки обмена IPD

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.

Критерии совместного доступа к IPD

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.

Совместное использование IPD Поддерживающий тип информации

  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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