Observational Study Protocol: LIVER-R
Launched by ASTRAZENECA · Feb 1, 2024
Trial Information
Current as of July 16, 2025
Recruiting
Keywords
ClinConnect Summary
The LIVER-R study is a clinical trial aimed at understanding how effective a treatment called durvalumab is for patients with certain types of liver and bile duct cancers. This study will gather information from patients who are receiving durvalumab as part of their regular treatment or through special access programs. The goal is to see how well patients do over time when treated with this medication in real-life situations, rather than in a controlled clinical trial setting. Researchers will collect various types of information, including how long patients live after starting treatment and any significant health events that occur during the study.
To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of primary hepatobiliary cancer, such as unresectable hepatocellular carcinoma (uHCC) or advanced biliary tract cancer (aBTC). It's important that the specific cancer type is approved for treatment with durvalumab in their country. Participants will not be eligible if they are currently involved in other clinical trials for investigational treatments or if they have received other systemic therapies for their cancer around the same time as starting the durvalumab regimen. By joining this study, participants can contribute valuable information that may help improve cancer treatments in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥18 years and a lawful adult in the country at the index date
- • 2. Confirmed presence of malignancy of primary hepatobiliary cancer (i.e., uHCC or aBTC) by the treating physician
- • 3. Type of hepatobiliary cancer indication is approved to be treated (i.e., positive phase 3 clinical trial read out for HIMALAYA or TOPAZ 1) with a durvalumab based regimen in the respective country or was administered as part of an EAP
- • 4. Informed consent was obtained as per country level regulations on or after the index date
- 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. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date (e.g., uHCC or aBTC patient who received a systemic treatment for unresectable HCC or advanced BTC, respectively, prior to initiating durvalumab based regimen)
- • 3. Received a liver transplant during the baseline period
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Temple, Texas, United States
Los Angeles, California, United States
Spokane, Washington, United States
Augusta, Georgia, United States
Walnut Creek, California, United States
Bethlehem, Pennsylvania, United States
Gainesville, Florida, United States
Canton, Ohio, United States
Santander, Cantabria, Spain
Baton Rouge, Louisiana, United States
Hinsdale, Illinois, United States
Philadelphia, Pennsylvania, United States
Heidelberg, Victoria, Australia
Berlin, , Germany
San Juan, , Puerto Rico
El Palmar, Murcia, Spain
Tampa, Florida, United States
Melbourne, Victoria, Australia
Tel Aviv, , Israel
Garran, Australian Capital Territory, Australia
Barcelona, , Spain
Porto Alegre, Rio Grande Do Sul, Brazil
Halifax, Nova Scotia, Canada
Mobile, Alabama, United States
Evergreen Park, Illinois, United States
Phoenix, Arizona, United States
Kyoto Shi, Kyoto, Japan
Jerusalem, , Israel
Bonheiden, Antwerp, Belgium
Ourense, Galicia, Spain
Murdoch, Western Australia, Australia
Pamplona, , Spain
Sao Paulo, , Brazil
Kashiwa Shi, Chiba, Japan
Athens, Attica, Greece
White Plains, New York, United States
Kaohsiung City, , Taiwan
Hamburg, , Germany
Sendai Shi, Miyagi, Japan
Clermont, Florida, United States
Dresden, Saxony, Germany
Bucuresti, , Romania
Singapore, , Singapore
Coronado, California, United States
Santiago De Compostela, A Coruna, Spain
Dresden, Saxony, Germany
Larissa, Thessaly, Greece
Taipei City, , Taiwan
Hamburg, , Germany
Augsburg, Bavaria, Germany
Hannover, Lower Saxony, Germany
Dortmund, North Rhine Westphalia, Germany
Naples, Campania, Italy
Brescia, Lombardy, Italy
Strasbourg, Alsace, France
Grenoble, Auvergne Rhône Alpes, France
St Malo, Bretagne, France
Avignon, Provence Alpes Cote D'azur, France
Marseille, Provence Alpes Cote D'azur, France
Stolberg, North Rhine Westphalia, Germany
Thessaloniki, Central Macedonia, Greece
Mulhouse, Grand Est, France
Halle (Saale), Saxony Anhalt, Germany
Dallas, Texas, United States
Mulhouse, Grand Est, France
Paris, Ile De France, France
Heidenheim, Baden Württemberg, Germany
Mannheim, Baden Württemberg, Germany
Marburg, Hesse, Germany
Bochum, North Rhine Westphalia, Germany
Moers, North Rhine Westphalia, Germany
Koblenz, Rhineland Palatinate, Germany
Halle (Saale), Saxony Anhalt, Germany
Neumuenster, Schleswig Holstein, Germany
Athens, Attica, Greece
Larissa, Thessaly, Greece
Rome, Lazio, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Rozzano, Lombardy, Italy
Turin, Piemonte, Italy
Pisa, Tuscany, Italy
Taoyuan City, , Taiwan
Linz, Upper Austria, Austria
Goettingen, Lower Saxony, Germany
Hannover, Lower Saxony, Germany
Aachen, North Rhine Westphalia, Germany
Chaidari, Athens, Greece
Thessaloniki, Central Macedonia, Greece
Poitiers, Nouvelle Aquitaine, France
Grenoble, Auvergne Rhone Alpes, France
Heidenheim, Baden Württemberg, Germany
Mannheim, Baden Württemberg, Germany
Koblenz, Rhineland Palatinate, Germany
Chaidari, Athens, Greece
Rome, Lazio, Italy
Milan, Lombardy, Italy
Rozzano, Lombardy, Italy
Turin, Piemonte, Italy
Pisa, Tuscany, Italy
Nagoya, Aichi Ken, Japan
Kanazawa Shi, Ishikawa, Japan
Heidelberg, Victoria, Australia
Grenoble, Auvergne Rh Ne Alpes, France
Boulogne Sur Mer, Hauts De France, France
Paris, Ile De France, France
Heidenheim, Baden W Rttemberg, Germany
Mannheim, Baden W Rttemberg, Germany
Berlin, , Germany
Hamburg, , Germany
Athens, Attica, Greece
Garran, Australian Capital Territory, Australia
Curitiba, Parana, Brazil
Yokohama Shi, Kanagawa, Japan
Birmingham, Alabama, United States
Murdoch, Western Australia, Australia
Leuven, Brabant, Belgium
Stene, West Flanders, Belgium
Recife Pe, , Brazil
Muenchen, Bavaria, Germany
Bremenhaven, Bremen, Germany
Kassel, Hesse, Germany
Magdeburg, Saxony Anhalt, Germany
Monserrato, Sardinia, Italy
Osaka Sayama, Osaka, Japan
Santiago De Compostela, A Coru A, Spain
Lisboa, , Portugal
Liege, Wallonia, Belgium
Heidenheim, Baden Wurttemberg, Germany
Konstanz, Baden Wurttemberg, Germany
Mannheim, Baden Wurttemberg, Germany
Wiesbaden, Hesse Land, Germany
Halle (Saale), Saxony Anhalt, Germany
Leipzig, Saxony, Germany
Ramat Gan, Tel Aviv, Israel
Cluj, , Romania
Poniente Sur, Cordoba, Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported