Clinical Trial Radar

Name: An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers
Creator: AstraZeneca
Published: 2024-02-12
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT06252753 (LIVER-R) for Hepatobiliary Cancers is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Observational Study Protocol: LIVER-R 4,490 Real-World Evidence Observational Overall Survival

Recruiting

Clinical Trial NCT06252753 (LIVER-R) is an observational study for Hepatobiliary Cancers that is recruiting. It started on 16 March 2023 with plans to enroll 4,490 participants. Led by AstraZeneca, it is expected to complete by 30 December 2030. The latest data from ClinicalTrials.gov was last updated on 26 December 2025.

Brief 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 acce...Show More

Detailed Description

LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately 2500 pts with unresectable hepatocellular carcinoma (uHCC; n=1135) or advanced biliary tract cancers (aBTCs; n=1355) across 22 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-ti...Show More

Official Title

An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers

Conditions

Hepatobiliary Cancers

Publications

Ikeda M, Worns MA, Akce M, Hsu C, Tebbutt NC, Casadei-Gardini A, Sah J, Farid-Kapadia M, Stirnadel-Farrant HA, Paskow MJ, Baur B, Melillo G, Schmidt J, Daktera A, Knox JJ. LIVER-R study protocol: a global real-world study of durvalumab-based regimens in patients with hepatobiliary cancers. Fut...

Other Study IDs

LIVER-R
D419CR00035

NCT ID Number

NCT06252753

Start Date (Actual)

2023-03-16

Last Update Posted

2025-12-26

Completion Date (Estimated)

2030-12-30

Enrollment (Estimated)

4,490

Study Type

Observational

Status

Recruiting

Keywords

Hepatobiliary cancer
Unresectable hepatocellular carcinoma (uHCC)
Advanced biliary tract cancer (aBTC)
Durvalumab
Observatory
Real-world

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
unresectable hepatocellular carcinoma (uHCC) unresectable hepatocellular carcinoma (uHCC)	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).
advanced biliary tract cancer (aBTC) advanced biliary tract cancer (aBTC)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world overall survival (rwOS)	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, 24 months (both aBTC and uHCC), and 36 months (uHCC), median OS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world duration of treatment (rwDOT)	rwDOT will be calculated for each systemic treatment as the time from the index date to date of discontinuation for any reason.	rwDOT will be assessed as median DOT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Real-world progression free survival (rwPFS)	rwPFS will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment or death, whichever is earlier.	rwPFS will be assessed as PFS rates at 6, 12, 24 months (both aBTC and uHCC), and 36 months (uHCC), median PFS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.
Real-world time to progression (rwTTP)	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 median TTP for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Real-world time to next treatment (rwTTNT)	rwTTNT will be calculated as the time from the index date to the date of initiation of the next treatment.	rwTTNT will be assessed as median TTNT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Real-world recurrence free survival (rwRFS)	rwRFS will be defined as the time from the index date to the 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, 24 months (both aBTC and uHCC), and 36 months (uHCC), median RFS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.
Real-world time to recurrence (rwTTR)	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 median TTR for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Patient demographic and clinical characteristics	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.
Percentage of patients receiving each treatment regimen	Treatment patterns will be calculated from the index date until death, loss to follow-up, withdrawal from the study, or end of the study, whichever is earliest.	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 maximum follow-up of 2 years for patients with aBTCs or 3 years for patients with uHCC.
Clinically significant events (CSEs) of interest leading to a medical intervention	CSEs of interest leading to medical intervention including durvalumab based 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 regimen or death, whichever occurs first.

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Age ≥18 years and a lawful adult in the country at the index date
Confirmed presence of malignancy of primary hepatobiliary cancer (i.e., uHCC or aBTC) by the treating physician
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
Informed consent was obtained as per country level regulations on or after the index date

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
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)
Received a liver transplant during the baseline period

AstraZeneca

ICON plc

Study Central Contact

Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]

138 Study Locations in 21 Countries

Australia

Australian Capital Territory

Research Site, Garran, Australian Capital Territory, 2605, Australia

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Victoria

Research Site, Heidelberg, Victoria, 3084, Australia

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Research Site, Melbourne, Victoria, 3004, Australia

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Western Australia

Research Site, Murdoch, Western Australia, 6150, Australia

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United States

Alabama

Research Site, Birmingham, Alabama, 35233-1932, United States

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Research Site, Mobile, Alabama, 36604, United States

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Arizona

Research Site, Phoenix, Arizona, 85004, United States

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California

Research Site, Coronado, California, 92118, United States

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Research Site, Los Angeles, California, 90048, United States

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Research Site, Walnut Creek, California, 94598, United States

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Florida

Research Site, Clermont, Florida, 34711, United States

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Research Site, Gainesville, Florida, 32610, United States

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Research Site, Tampa, Florida, 33606, United States

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Georgia

Research Site, Augusta, Georgia, 30912, United States

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Illinois

Research Site, Evergreen Park, Illinois, 60805, United States

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Research Site, Hinsdale, Illinois, 60521, United States

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Louisiana

Research Site, Baton Rouge, Louisiana, 70808, United States

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Missouri

Research Site, Osage Beach, Missouri, 65065, United States

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New York

Research Site, White Plains, New York, 10601, United States

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Ohio

Research Site, Canton, Ohio, 44718, United States

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Pennsylvania

Research Site, Bethlehem, Pennsylvania, 18015, United States

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Research Site, Philadelphia, Pennsylvania, 19141, United States

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Texas

Research Site, Dallas, Texas, 75390-8567, United States

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Research Site, Temple, Texas, 76508, United States

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Washington

Research Site, Spokane, Washington, 99204, United States

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Austria

Lower Austria

Research Site, Sankt Pölten, Lower Austria, 3100, Austria

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Upper Austria

Research Site, Linz, Upper Austria, 4010, Austria

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Vienna

Research Site, Vienna, Vienna, 1090, Austria

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Belgium

Anderlecht

Research Site, Brussels, Anderlecht, 1070, Belgium

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Antwerp

Research Site, Bonheiden, Antwerp, 2820, Belgium

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Research Site, Edegem, Antwerp, 2650, Belgium

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Brabant

Research Site, Leuven, Brabant, 3000, Belgium

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Wallonia

Research Site, Liège, Wallonia, 4000, Belgium

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West Flanders

Research Site, Stene, West Flanders, 8400, Belgium

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Brazil

Paraná

Research Site, Curitiba, Paraná, 81480-580, Brazil

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Recife - PE

Research Site, Recife - PE, Recife - PE, 50070-490, Brazil

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Rio Grande do Sul

Research Site, Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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São Paulo

Research Site, Morumbi, São Paulo, 05651-901, Brazil

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Research Site, São Paulo, 01246-000, Brazil

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Research Site, São Paulo, 04538-132, Brazil

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Canada

Nova Scotia

Research Site, Halifax, Nova Scotia, B3H 2Y9, Canada

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France

Alsace

Research Site, Strasbourg, Alsace, 67000, France

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Auvergne-Rhône-Alpes

Research Site, Grenoble, Auvergne-Rhône-Alpes, 38700, France

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Brittany Region

Research Site, St-Malo, Brittany Region, 35403, France

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Grand Est

Research Site, Mulhouse, Grand Est, 68100, France

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Hauts-de-France

Research Site, Boulogne-sur-Mer, Hauts-de-France, 62200, France

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Nouvelle-Aquitaine

Research Site, Poitiers, Nouvelle-Aquitaine, 86000, France

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Provence-Alpes-Côte d'Azur Region

Research Site, Avignon, Provence-Alpes-Côte d'Azur Region, 84918, France

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Research Site, Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France

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Île-de-France Region

Research Site, Paris, Île-de-France Region, 75012, France

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Research Site, Paris, Île-de-France Region, 75014, France

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Germany

Baden W Rttemberg

Research Site, Heidenheim, Baden W Rttemberg, 89522, Germany

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Baden-Wurttemberg

Research Site, Konstanz, Baden-Wurttemberg, 78484, Germany

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Research Site, Mannheim, Baden-Wurttemberg, 68167, Germany

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Research Site, Schorndorf, Baden-Wurttemberg, 73614, Germany

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Research Site, Stuttgart, Baden-Wurttemberg, 70174, Germany

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Bavaria

Research Site, Augsburg, Bavaria, 86150, Germany

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Research Site, Munich, Bavaria, 81377, Germany

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City state Bremen

Research Site, Bremenhaven, City state Bremen, 27574, Germany

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Hesse

Research Site, Kassel, Hesse, 34125, Germany

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Research Site, Marburg, Hesse, 35033, Germany

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Hesse Land

Research Site, Wiesbaden, Hesse Land, 65189, Germany

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Lower Saxony

Research Site, Göttingen, Lower Saxony, 37075, Germany

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Research Site, Hanover, Lower Saxony, 30161, Germany

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Research Site, Hanover, Lower Saxony, 30459, Germany

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North Rhine-Westphalia

Research Site, Aachen, North Rhine-Westphalia, 52074, Germany

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Research Site, Bochum, North Rhine-Westphalia, 44892, Germany

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Research Site, Dortmund, North Rhine-Westphalia, 44137, Germany

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Research Site, Moers, North Rhine-Westphalia, 47441, Germany

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Research Site, Stolberg, North Rhine-Westphalia, 52222, Germany

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Rhineland-Palatinate

Research Site, Koblenz, Rhineland-Palatinate, 56073, Germany

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Saxony

Research Site, Dresden, Saxony, 1307, Germany

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Research Site, Leipzig, Saxony, 4103, Germany

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Saxony-Anhalt

Research Site, Halle, Saxony-Anhalt, 06108, Germany

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Research Site, Magdeburg, Saxony-Anhalt, 39120, Germany

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Schleswig-Holstein

Research Site, Neumünster, Schleswig-Holstein, 24534, Germany

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Research Site, Berlin, 13353, Germany

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Research Site, Hamburg, 20259, Germany

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Research Site, Hamburg, 22291, Germany

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Greece

Athens

Research Site, Chaïdári, Athens, 12462, Greece

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Attica

Research Site, Athens, Attica, 11527, Greece

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Research Site, Athens, Attica, 14564, Greece

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Central Macedonia

Research Site, Thessaloniki, Central Macedonia, 54639, Greece

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Research Site, Thessaloniki, Central Macedonia, 55236, Greece

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Thessaly

Research Site, Larissa, Thessaly, 41110, Greece

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Israel

Northern Didstrict

Research Site, Nahariya, Northern Didstrict, 22100, Israel

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Tel Aviv

Research Site, Ramat Gan, Tel Aviv, 52621, Israel

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Research Site, Jerusalem, 9103102, Israel

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Research Site, Tel Aviv, 6423906, Israel

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Italy

Campania

Research Site, Naples, Campania, 80131, Italy

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Lazio

Research Site, Rome, Lazio, 00128, Italy

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Research Site, Rome, Lazio, 00168, Italy

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Lombardy

Research Site, Brescia, Lombardy, 25123, Italy

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Research Site, Milan, Lombardy, 20132, Italy

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Research Site, Milan, Lombardy, 20133, Italy

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Research Site, Rozzano, Lombardy, 20089, Italy

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Piedmont

Research Site, Turin, Piedmont, 10126, Italy

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Sardinia

Research Site, Monserrato, Sardinia, 09042, Italy

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Tuscany

Research Site, Pisa, Tuscany, 56124, Italy

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Japan

Aichi-ken

Research Site, Nagoya, Aichi-ken, 466-8550, Japan

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Chiba

Research Site, Kashiwa-shi, Chiba, 277-8577, Japan

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Fukuoka

Research Site, Kurume, Fukuoka, 830-0011, Japan

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Ishikawa-ken

Research Site, Kanazawa, Ishikawa-ken, 920-8641, Japan

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Kanagawa

Research Site, Yokohama, Kanagawa, 241-8515, Japan

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Kyoto

Research Site, Kyoto, Kyoto, 606-8507, Japan

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Miyagi

Research Site, Sendai, Miyagi, 980-8574, Japan

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Osaka

Research Site, Ōsaka-sayama, Osaka, 589-8511, Japan

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Portugal

Research Site, Lisbon, 1400 - 038, Portugal

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Research Site, Lisbon, 1649-028, Portugal

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Puerto Rico

Rio Piedras

Research Site, San Juan, Rio Piedras, 00935, Puerto Rico

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Romania

Research Site, Bucharest, 22328, Romania

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Research Site, Cluj-Napoca, 400162, Romania

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Research Site, Iași, 700483, Romania

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Saudi Arabia

Ar Riyadh

Research Site, Riyadh, Ar Riyadh, 12231, Saudi Arabia

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Mecca Region

Research Site, Jeddah, Mecca Region, 22384, Saudi Arabia

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Singapore

Research Site, Singapore, 329563, Singapore

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Spain

A Coruna

Research Site, Santiago de Compostela, A Coruna, 15706, Spain

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Aragon

Research Site, Zaragoza, Aragon, 50009, Spain

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Cantabria

Research Site, Santander, Cantabria, 39008, Spain

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Castille and León

Research Site, Burgos, Castille and León, 9006, Spain

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Cordoba

Research Site, Poniente Sur, Cordoba, 14004, Spain

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Galicia

Research Site, Ourense, Galicia, 32005, Spain

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Murcia

Research Site, El Palmar, Murcia, 30120, Spain

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Research Site, Barcelona, 8035, Spain

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Research Site, Madrid, 28007, Spain

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Research Site, Madrid, 28034, Spain

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Research Site, Madrid, 28040, Spain

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Research Site, Oviedo, 33011, Spain

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Research Site, Pamplona, 31008, Spain

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Research Site, Santa Cruz de Tenerife, 38010, Spain

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Research Site, Seville, 41009, Spain

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Research Site, Valencia, 46010, Spain

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Switzerland

Research Site, Zurich, 8032, Switzerland

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Taiwan

Research Site, Kaohsiung City, 82445, Taiwan

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Research Site, Taipei, 100225, Taiwan

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Research Site, Taipei, 11217, Taiwan

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Research Site, Taoyuan, 33305, Taiwan

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United Arab Emirates

Abu Dhabi Emirate

Research Site, Mohammed Bin Zayed City, Abu Dhabi Emirate, 92510, United Arab Emirates

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Observational Study Protocol: LIVER-R 4,490 Real-World Evidence Observational Overall Survival

Inclusion Criteria

Exclusion Criteria