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Observational Study Protocol: LIVER-R

NCT ID: NCT06252753

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-16

Study Completion Date

2030-12-30

Brief Summary

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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).

Detailed Description

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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-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 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 regimen) and a follow-up period to 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. 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.

Conditions

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Hepatobiliary Cancers

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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unresectable hepatocellular carcinoma (uHCC)

unresectable hepatocellular carcinoma (uHCC)

Durvalumab-based combination therapies in observational study setting

Intervention Type OTHER

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

Intervention Type OTHER

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Imfinzi Imfinzi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ICON plc

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Birmingham, Alabama, United States

Site Status RECRUITING

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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

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Countries

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United States Australia Austria Belgium Brazil Canada France Germany Greece Israel Italy Japan Portugal Puerto Rico Romania Saudi Arabia Singapore Spain Switzerland Taiwan United Arab Emirates

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

References

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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. Future Oncol. 2025 Dec;21(29):3739-3748. doi: 10.1080/14796694.2025.2589057. Epub 2025 Nov 24.

Reference Type DERIVED
PMID: 41277677 (View on PubMed)

Other Identifiers

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D419CR00035

Identifier Type: -

Identifier Source: org_study_id