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Observational Study Protocol: LIVER-R
Sponsor: AstraZeneca
Summary
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 multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with 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 durvalumab-based regimens 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, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).
Official title: An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
OBSERVATIONAL
Enrollment
4490
Start Date
2023-03-16
Completion Date
2030-12-30
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
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).
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.
Locations (138)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Coronado, California, United States
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Los Angeles, California, United States
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Walnut Creek, California, United States
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Clermont, Florida, United States
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Gainesville, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
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Evergreen Park, Illinois, United States
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Hinsdale, Illinois, United States
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Baton Rouge, Louisiana, United States
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Osage Beach, Missouri, United States
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White Plains, New York, United States
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Canton, Ohio, United States
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Bethlehem, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Temple, Texas, United States
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Spokane, Washington, United States
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Garran, Australian Capital Territory, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Sankt Pölten, Lower Austria, Austria
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Linz, Upper Austria, Austria
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Vienna, Vienna, Austria
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Brussels, Anderlecht, Belgium
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Bonheiden, Antwerp, Belgium
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Edegem, Antwerp, Belgium
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Leuven, Brabant, Belgium
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Liège, Wallonia, Belgium
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Stene, West Flanders, Belgium
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Curitiba, Paraná, Brazil
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Recife - PE, Recife - PE, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Morumbi, São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Halifax, Nova Scotia, Canada
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Strasbourg, Alsace, France
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Grenoble, Auvergne-Rhône-Alpes, France
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St-Malo, Brittany Region, France
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Mulhouse, Grand Est, France
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Boulogne-sur-Mer, Hauts-de-France, France
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Poitiers, Nouvelle-Aquitaine, France
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Avignon, Provence-Alpes-Côte d'Azur Region, France
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Marseille, Provence-Alpes-Côte d'Azur Region, France
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Paris, Île-de-France Region, France
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Paris, Île-de-France Region, France
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Heidenheim, Baden W Rttemberg, Germany
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Konstanz, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Schorndorf, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Munich, Bavaria, Germany
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Bremenhaven, City state Bremen, Germany
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Kassel, Hesse, Germany
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Marburg, Hesse, Germany
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Wiesbaden, Hesse Land, Germany
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Göttingen, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Aachen, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Dortmund, North Rhine-Westphalia, Germany
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Moers, North Rhine-Westphalia, Germany
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Stolberg, North Rhine-Westphalia, Germany
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Koblenz, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Neumünster, Schleswig-Holstein, Germany
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Berlin, Germany
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Hamburg, Germany
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Hamburg, Germany
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Chaïdári, Athens, Greece
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Athens, Attica, Greece
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Athens, Attica, Greece
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Thessaloniki, Central Macedonia, Greece
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Thessaloniki, Central Macedonia, Greece
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Larissa, Thessaly, Greece
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Nahariya, Northern Didstrict, Israel
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Ramat Gan, Tel Aviv, Israel
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Jerusalem, Israel
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Tel Aviv, Israel
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Naples, Campania, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Brescia, Lombardy, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Rozzano, Lombardy, Italy
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Turin, Piedmont, Italy
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Monserrato, Sardinia, Italy
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Pisa, Tuscany, Italy
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Nagoya, Aichi-ken, Japan
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Kashiwa-shi, Chiba, Japan
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Kurume, Fukuoka, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Ōsaka-sayama, Osaka, Japan
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Lisbon, Portugal
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Lisbon, Portugal
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San Juan, Rio Piedras, Puerto Rico
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Riyadh, Ar Riyadh, Saudi Arabia
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Jeddah, Mecca Region, Saudi Arabia
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Singapore, Singapore
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Santiago de Compostela, A Coruna, Spain
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Zaragoza, Aragon, Spain
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Santander, Cantabria, Spain
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Burgos, Castille and León, Spain
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Poniente Sur, Cordoba, Spain
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Ourense, Galicia, Spain
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El Palmar, Murcia, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Oviedo, Spain
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Pamplona, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Valencia, Spain
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Zurich, Switzerland
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Mohammed Bin Zayed City, Abu Dhabi Emirate, United Arab Emirates