Observational Study Protocol: LIVER-R (LIVER-R)

September 4, 2026 updated by: AstraZeneca

An Observational Multi-Center Study to Evaluate Real-World Treatment Outcomes With or Without Durvalumab-Based Regimens in Hepatobiliary Cancers

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria General Inclusion Criteria

All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:

  1. Age ≥18 years and a lawful adult in the country at the index date
  2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)
  3. Decision to treat was made independently and prior to obtaining informed consent
  4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)

aBTC Specific Inclusion Criteria

A patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable aBTC
  2. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

uHCC Specific Inclusion Criteria

A patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. Patient has unresectable uHCC
  2. Not eligible for LRT, as well as for those who progressed following LRT
  3. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)

eeHCC Specific Inclusion Criteria

A patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh A-B7
  3. Disease not amenable to curative treatment but amenable to LRT at index
  4. Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024
  5. Patients eligible for LRT with palliative intent such as TACE/ TARE/transarterial infusion chemotherapy (TAIC)/ hepatic arterial infusion chemotherapy (HAIC)/transarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT

EMERALD Specific Inclusion Criteria

A patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:

  1. HCC confirmed by radiological or histological diagnosis
  2. Child-Pugh score of A-B7
  3. Liver-confined disease not amenable to curative treatment but amenable to LRT at index
  4. Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)

Exclusion Criteria

General Exclusion Criteria

A patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:

  1. Currently/was participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date
  2. Second primary malignancy prior to HCC or BTC diagnosis

aBTC Specific Exclusion Criteria

A patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible

uHCC Specific Exclusion Criteria

A patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Received a liver transplant during the baseline period
  2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date

eeHCC Specific Exclusion Criteria

A patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

EMERALD Specific Exclusion Criteria

A patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:

  1. Eligible for curative therapy at the time of receiving LRT (ablation)
  2. Extrahepatic spread
  3. Portal vein tumor thrombosis (PVTT) of VP3/4
  4. Receipt of systemic therapy prior to index LRT in the baseline period
  5. Liver transplant any time prior to index

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: 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).
Other Names:
  • Imfinzi
Other: 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.
Other Names:
  • 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
Other: 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).
Other Names:
  • Imfinzi
Other: 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.
Other Names:
  • 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)
Other: 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)
Other: Durvalumab-based combination therapies in observational study settings
Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected
Other Names:
  • Imfinzi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real-world overall survival (rwOS) in all participants
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant events (CSEs) of interest leading to a medical intervention in all participants
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

ICON plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D419CR00035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share only the redacted CSR synopsis

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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