Observasjonsstudieprotokoll: LIVER-R (LIVER-R)
En observasjonell multisenterstudie for å evaluere virkelige behandlingsresultater av Durvalumab-baserte regimer i lever- og gallekreft
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 ).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Annen: Durvalumab-based combination therapies in observational study setting
- Annen: Durvalumab-based combination therapies in observational study setting
- Annen: Non Durvalumab-based therapies in observational study setting
- Annen: Durvalumab-based combination therapies in observational study settings
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studiesteder
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
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Victoria
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Heidelberg, Victoria, Australia, 3084
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Melbourne, Victoria, Australia, 3004
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Western Australia
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Murdoch, Western Australia, Australia, 6150
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Anderlecht
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Brussels, Anderlecht, Belgia, 1070
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Antwerp
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Bonheiden, Antwerp, Belgia, 2820
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Edegem, Antwerp, Belgia, 2650
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Brabant
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Leuven, Brabant, Belgia, 3000
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Wallonia
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Liège, Wallonia, Belgia, 4000
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West Flanders
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Stene, West Flanders, Belgia, 8400
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São Paulo, Brasil, 04538-132
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São Paulo, Brasil, 01246-000
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Paraná
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Curitiba, Paraná, Brasil, 81480-580
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Recife - PE
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Recife - PE, Recife - PE, Brasil, 50070-490
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-001
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São Paulo
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Morumbi, São Paulo, Brasil, 05651-901
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G-1Z2
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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London, Ontario, Canada, N6A 5W9
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Abu Dhabi Emirate
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Mohammed Bin Zayed City, Abu Dhabi Emirate, De forente arabiske emirater, 92510
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Dubai
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Deira, Dubai, De forente arabiske emirater, 7272
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Alabama
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Birmingham, Alabama, Forente stater, 35233-1932
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Mobile, Alabama, Forente stater, 36604
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Arizona
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Phoenix, Arizona, Forente stater, 85004
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California
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Coronado, California, Forente stater, 92118
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Los Angeles, California, Forente stater, 90048
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Walnut Creek, California, Forente stater, 94598
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Florida
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Clermont, Florida, Forente stater, 34711
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Gainesville, Florida, Forente stater, 32610
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Tampa, Florida, Forente stater, 33606
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Georgia
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Augusta, Georgia, Forente stater, 30912
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Illinois
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Evergreen Park, Illinois, Forente stater, 60805
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Hinsdale, Illinois, Forente stater, 60521
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
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Missouri
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Osage Beach, Missouri, Forente stater, 65065
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New York
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White Plains, New York, Forente stater, 10601
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Ohio
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Canton, Ohio, Forente stater, 44718
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Pennsylvania
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Bethlehem, Pennsylvania, Forente stater, 18015
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Lancaster, Pennsylvania, Forente stater, 17604
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Philadelphia, Pennsylvania, Forente stater, 19141
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Pittsburgh, Pennsylvania, Forente stater, 15212
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Texas
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Dallas, Texas, Forente stater, 75390-8567
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Temple, Texas, Forente stater, 76508
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Washington
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Spokane, Washington, Forente stater, 99204
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Alsace
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Strasbourg, Alsace, Frankrike, 67000
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Auvergne-Rh ne-Alpes
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Grenoble, Auvergne-Rh ne-Alpes, Frankrike, 38700
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Brittany Region
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St-Malo, Brittany Region, Frankrike, 35403
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Grand Est
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Mulhouse, Grand Est, Frankrike, 68100
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Hauts-de-France
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Boulogne-sur-Mer, Hauts-de-France, Frankrike, 62200
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New Aquitaine
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Poitiers, New Aquitaine, Frankrike, 86000
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Provence-Alpes-Côte d'Azur Region
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Avignon, Provence-Alpes-Côte d'Azur Region, Frankrike, 84918
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Marseille, Provence-Alpes-Côte d'Azur Region, Frankrike, 13008
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Île-de-France Region
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Paris, Île-de-France Region, Frankrike, 75012
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Paris, Île-de-France Region, Frankrike, 75014
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Athens
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Chaïdári, Athens, Hellas, 12462
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Attica
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Athens, Attica, Hellas, 11527
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Athens, Attica, Hellas, 14564
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Central Macedonia
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Thessaloniki, Central Macedonia, Hellas, 55236
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Thessaloniki, Central Macedonia, Hellas, 54639
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Thessaly
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Larissa, Thessaly, Hellas, 41110
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Jerusalem, Israel, 9103102
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Tel Aviv, Israel, 6423906
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Northern Didstrict
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Nahariya, Northern Didstrict, Israel, 22100
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 52621
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Campania
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Naples, Campania, Italia, 80131
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Lazio
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Rome, Lazio, Italia, 00128
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Rome, Lazio, Italia, 00168
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Lombardy
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Brescia, Lombardy, Italia, 25123
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Milan, Lombardy, Italia, 20132
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Milan, Lombardy, Italia, 20133
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Rozzano, Lombardy, Italia, 20089
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Piedmont
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Turin, Piedmont, Italia, 10126
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Sardinia
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Monserrato, Sardinia, Italia, 09042
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Tuscany
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Pisa, Tuscany, Italia, 56124
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 466-8550
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
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Kyoto
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Kyoto, Kyoto, Japan, 606-8507
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
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Osaka
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Ōsaka-sayama, Osaka, Japan, 589-8511
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Akershus
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Lorenskog, Akershus, Norge, 1478
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Hordaland
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Bergen, Hordaland, Norge, 5021
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Stlandet
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Oslo, Stlandet, Norge, 379
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Faro, Portugal, 8000-386
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Lisbon, Portugal, 1400 - 038
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Lisbon, Portugal, 1649-028
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North
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Vila Real, North, Portugal, 5000-508
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Rio Piedras
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San Juan, Rio Piedras, Puerto Rico, 00935
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Bucharest, Romania, 22328
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Cluj-Napoca, Romania, 400162
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Craiova, Romania, 200347
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Iași, Romania, 700483
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Ar Riyadh
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Riyadh, Ar Riyadh, Saudi-Arabia, 12231
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Mecca Region
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Jeddah, Mecca Region, Saudi-Arabia, 22384
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Singapore, Singapore, 169610
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Singapore, Singapore, 329563
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Barcelona, Spania, 8035
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Madrid, Spania, 28007
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Madrid, Spania, 28034
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Madrid, Spania, 28040
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Madrid, Spania, 28041
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Oviedo, Spania, 33011
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Pamplona, Spania, 31008
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Santa Cruz de Tenerife, Spania, 38010
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Seville, Spania, 41009
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Valencia, Spania, 46010
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A Coru A
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Santiago de Compostela, A Coru A, Spania, 15706
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Aragon
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Zaragoza, Aragon, Spania, 50009
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C Rdoba
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Poniente Sur, C Rdoba, Spania, 14004
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Cantabria
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Santander, Cantabria, Spania, 39008
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Castile-Le N
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Burgos, Castile-Le N, Spania, 9006
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Galicia
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Ourense, Galicia, Spania, 32005
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Madrid
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Majadahonda, Madrid, Spania, 28222
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Murcia
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El Palmar, Murcia, Spania, 30120
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Zurich, Sveits, 8032
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Canton of Vaud
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Lausanne, Canton of Vaud, Sveits, 1005
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Kaohsiung City, Taiwan, 82445
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Taipei, Taiwan, 11217
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Taipei, Taiwan, 100225
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Taoyuan City, Taiwan, 33305
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Taichung City
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Taichung, Taichung City, Taiwan, 40705
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Berlin, Tyskland, 13353
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Berlin, Tyskland, 14165
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Bremen, Tyskland, 28211
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Hamburg, Tyskland, 22291
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Hamburg, Tyskland, 20259
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Baden W Rttemberg
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Heidenheim, Baden W Rttemberg, Tyskland, 89522
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Baden-W Rttemberg
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Konstanz, Baden-W Rttemberg, Tyskland, 78484
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Mannheim, Baden-W Rttemberg, Tyskland, 68167
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Schorndorf, Baden-W Rttemberg, Tyskland, 73614
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Stuttgart, Baden-W Rttemberg, Tyskland, 70174
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Bavaria
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Augsburg, Bavaria, Tyskland, 86150
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Munich, Bavaria, Tyskland, 81377
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Free Hanseatic City of Bremen
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Bremenhaven, Free Hanseatic City of Bremen, Tyskland, 27574
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Hesse
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Kassel, Hesse, Tyskland, 34125
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Marburg, Hesse, Tyskland, 35033
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Hesse Land
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Wiesbaden, Hesse Land, Tyskland, 65189
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Lower Saxony
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Göttingen, Lower Saxony, Tyskland, 37075
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Hanover, Lower Saxony, Tyskland, 30161
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Hanover, Lower Saxony, Tyskland, 30459
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Mecklenburg-Vorpommern
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Rostock, Mecklenburg-Vorpommern, Tyskland, 18057
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Tyskland, 52074
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Bochum, North Rhine-Westphalia, Tyskland, 44892
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Cologne, North Rhine-Westphalia, Tyskland, 50937
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Dortmund, North Rhine-Westphalia, Tyskland, 44137
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Moers, North Rhine-Westphalia, Tyskland, 47441
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Stolberg, North Rhine-Westphalia, Tyskland, 52222
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Rhineland-Palatinate
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Koblenz, Rhineland-Palatinate, Tyskland, 56073
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Saxony
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Dresden, Saxony, Tyskland, 1307
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Leipzig, Saxony, Tyskland, 4103
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Zwickau, Saxony, Tyskland, 8060
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Tyskland, 06108
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Magdeburg, Saxony-Anhalt, Tyskland, 39120
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Schleswig-Holstein
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Neumünster, Schleswig-Holstein, Tyskland, 24534
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Lower Austria
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Sankt Pölten, Lower Austria, Østerrike, 3100
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State of Vienna
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Vienna, State of Vienna, Østerrike, 1090
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Upper Austria
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Linz, Upper Austria, Østerrike, 4010
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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:
- Age ≥18 years and a lawful adult in the country at the index date
- Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)
- Decision to treat was made independently and prior to obtaining informed consent
- 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:
- Patient has unresectable aBTC
- 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:
- Patient has unresectable uHCC
- Not eligible for LRT, as well as for those who progressed following LRT
- 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:
- HCC confirmed by radiological or histological diagnosis
- Child-Pugh A-B7
- Disease not amenable to curative treatment but amenable to LRT at index
- Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024
- 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:
- HCC confirmed by radiological or histological diagnosis
- Child-Pugh score of A-B7
- Liver-confined disease not amenable to curative treatment but amenable to LRT at index
- 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:
- 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
- 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:
- Received a liver transplant during the baseline period
- 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:
- Received a liver transplant during the baseline period
- 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:
- Eligible for curative therapy at the time of receiving LRT (ablation)
- Extrahepatic spread
- Portal vein tumor thrombosis (PVTT) of VP3/4
- Receipt of systemic therapy prior to index LRT in the baseline period
- 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:
- Eligible for curative therapy at the time of receiving LRT (ablation)
- Extrahepatic spread
- Portal vein tumor thrombosis (PVTT) of VP3/4
- Receipt of systemic therapy prior to index LRT in the baseline period
- Liver transplant any time prior to index
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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 |
Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).
Andre navn:
Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.
Andre navn:
|
|
advanced biliary tract cancer (aBTC)
patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen |
Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).
Andre navn:
Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.
Andre navn:
|
|
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) |
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) |
Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Real-world overall survival (rwOS) in all participants
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinically significant events (CSEs) of interest leading to a medical intervention in all participants
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D419CR00035
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Plan to share only the redacted CSR synopsis
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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