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Observationsundersøgelsesprotokol: LIVER-R (LIVER-R)

4. september 2026 opdateret af: AstraZeneca

En observationel multicenterundersøgelse for at evaluere behandlingsresultater fra den virkelige verden af ​​Durvalumab-baserede regimer i lever- og galdekræft

I betragtning af antallet af forventede durvalumab-baserede behandlingslanceringer i lever- og galdekræftområdet i løbet af de næste 3 år, er der behov for at indfange aktuelle data fra den virkelige verden på tværs af disse indikationer. LIVER-R er et multinationalt, multicenter, observationsstudie af patienter med en bekræftet diagnose af hepatobiliær cancer behandlet med et durvalumab-baseret regime som en del af rutinemæssig klinisk praksis eller tidlig adgangsprogram (EAP; efter at EAP blev lukket i landet). Undersøgelsesdesignet vil omfatte primær og sekundær dataindsamling. Det primære formål med denne undersøgelse er at evaluere effektiviteten af ​​durvalumab-baserede regimer i den virkelige verden målt ved den virkelige verdens samlede overlevelse. Andre endepunkter omfatter demografi, kliniske karakteristika, klinisk signifikante begivenheder af interesse, behandlingsmønstre, samtidig medicinering og andre kliniske endepunkter i den virkelige verden (såsom behandlingsvarighed, progressionsfri overlevelse, tid til behandlingsprogression, tid til næste behandling, tilbagefald -fri overlevelse og tid til gentagelse af behandlingen).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

LIVER-R er et multi-center-studie i den virkelige verden, der sigter mod at indskrive ca. 2500 pts med inoperabelt hepatocellulært karcinom (uHCC; n=1135) eller fremskreden galdevejskræft (aBTC'er; n=1355) i 22 lande fra Nord- og Sydamerika, Europa, Mellemøsten og Asien-Stillehavsområdet. Undersøgelsesdesignet vil omfatte primær og sekundær dataindsamling. Primære data vil blive indsamlet i realtid under patientens rutinebesøg. Sekundære data vil blive indsamlet fra patientens journal ved indskrivning og på forudspecificerede undersøgelsestidspunkter (6-måneders intervaller). Undersøgelsespopulationen omfatter voksne patienter, hvis læge tidligere har truffet beslutningen om at behandle dem med et durvalumab-baseret regime for hepatobiliær cancer som en del af rutinemæssig klinisk praksis, eller patienter, der modtager behandling gennem EAP. Undersøgelsen vil omfatte en baseline-periode på op til 5 år før indeksdatoen (start af et Durvalumab-baseret regime) og en opfølgningsperiode til det tidligste dødsfald, tab til opfølgning, tilbagetrækning eller afslutning af undersøgelsen for en maksimal opfølgning på 2 år for patienter med aBTC eller 3 år for patienter med uHCC. Dette er en beskrivende, ikke-komparativ undersøgelse. Ingen formelle hypoteser skal testes. Alle beskrivende analyser vil blive udført separat for hver primær indikation for hepatobiliær cancer. Kaplan Meier-estimater vil blive udarbejdet for resultater fra tid til begivenhed.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

4000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Undersøgelsespopulationen omfatter patienter behandlet med et durvalumab-baseret regime for hepatobiliær cancer som en del af rutinemæssig klinisk praksis. Beslutningen om at behandle patienter med et durvalumab-baseret regime bør være uafhængigt af beslutningen om at inkludere patienter i undersøgelsen. Afhængigt af landet forventes det, at 15 til 400 patienter kan blive indskrevet i hvert deltagende land.

Beskrivelse

Inklusionskriterier:

  1. Alder ≥18 år og en lovlig voksen i landet på indeksdatoen
  2. Bekræftet tilstedeværelse af malignitet af primær hepatobiliær cancer (dvs. uHCC eller aBTC) af den behandlende læge
  3. Type af hepatobiliær cancerindikation er godkendt til at blive behandlet (dvs. positiv fase 3 klinisk undersøgelse udlæst for HIMALAYA eller TOPAZ 1) med et durvalumab-baseret regime i det respektive land eller blev administreret som en del af en EAP
  4. Informeret samtykke blev indhentet i henhold til reglerne på landeniveau på eller efter indeksdatoen

Ekskluderingskriterier:

  1. Deltager i øjeblikket/deltager eller planlægger at deltage i et hvilket som helst klinisk forsøg til forsøgsbehandling for hepatobiliær cancer på eller efter diagnosedatoen indtil indeksdatoen
  2. Modtaget andre systemiske terapier for hepatobiliær cancerindikation på eller efter diagnose-datoen til og med indeksdatoen (f.eks. uHCC- eller aBTC-patient, der modtog en systemisk behandling for henholdsvis inoperabel HCC eller fremskreden BTC, før påbegyndelse af durvalumab-baseret regime)
  3. Modtog en levertransplantation i baseline-perioden

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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
Andet: Durvalumab-baserede kombinationsterapier i observationsstudier
Data om patienter, der påbegyndte durvalumab-baserede regimer, inklusive STRIDE (Single Tremelimumab Regular Interval Durvalumab), vil blive indsamlet).
Andre navne:
  • Imfinzi
Andet: Durvalumab-baserede kombinationsterapier i observationsstudier
Data om patienter, der påbegyndte durvalumab-baserede regimer, inklusive kombinationer af durvalumab + kemoterapi (f.eks. Durvalumab + GemCis osv.), vil blive indsamlet.
Andre navne:
  • Imfinzi
advanced biliary tract cancer (aBTC)
patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen
Andet: Durvalumab-baserede kombinationsterapier i observationsstudier
Data om patienter, der påbegyndte durvalumab-baserede regimer, inklusive STRIDE (Single Tremelimumab Regular Interval Durvalumab), vil blive indsamlet).
Andre navne:
  • Imfinzi
Andet: Durvalumab-baserede kombinationsterapier i observationsstudier
Data om patienter, der påbegyndte durvalumab-baserede regimer, inklusive kombinationer af durvalumab + kemoterapi (f.eks. Durvalumab + GemCis osv.), vil blive indsamlet.
Andre navne:
  • Imfinzi
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)
Andet: 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)
Andet: Durvalumab-based combination therapies in observational study settings
Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected
Andre navne:
  • Imfinzi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

ICON plc

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. december 2023

Primær færdiggørelse (Anslået)

30. december 2030

Studieafslutning (Anslået)

30. december 2030

Datoer for studieregistrering

Først indsendt

21. december 2023

Først indsendt, der opfyldte QC-kriterier

1. februar 2024

Først opslået (Faktiske)

12. februar 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D419CR00035

Plan for individuelle deltagerdata (IPD)

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JA

IPD-planbeskrivelse

Planlæg kun at dele den redigerede CSR-synopsis

IPD-delingstidsramme

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IPD-delingsadgangskriterier

Når en anmodning er blevet godkendt, vil AstraZeneca give adgang til de anonymiserede individuelle data på patientniveau via det sikre forskningsmiljø Vivli.org. En underskrevet databrugsaftale (ikke-omsættelig kontrakt for dataadgangere) skal være på plads, før du får adgang til de anmodede oplysninger.

IPD-deling Understøttende informationstype

  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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