Observational Study Protocol: LIVER-R

NCT06252753 | Recruiting

• 1 other identifier: D419CR00035
• Study Type: observational
• Target: 4,490
• Locations: 20 countries
• Sites: 135

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 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).

Conditions

Hepatobiliary Cancers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Real-world duration of treatment (rwDOT)

  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 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 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 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 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.

Study Arms (2)

unresectable hepatocellular carcinoma (uHCC)

unresectable hepatocellular carcinoma (uHCC)

Other: Durvalumab-based combination therapies in observational study setting

advanced biliary tract cancer (aBTC)

advanced biliary tract cancer (aBTC)

Other: Durvalumab-based combination therapies in observational study setting

Interventions

Durvalumab-based combination therapies in observational study setting OTHER

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

Also known as: Imfinzi

unresectable hepatocellular carcinoma (uHCC)

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients treated with a durvalumab based regimen 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. Depending on the country, it is anticipated that 15 to 400 patients may be enrolled in each participating country.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ICON plc: collaborator
• AstraZeneca: lead

Study Sites (138)

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Birmingham, Alabama, 35233-1932, United States

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Mobile, Alabama, 36604, United States

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Phoenix, Arizona, 85004, United States

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Coronado, California, 92118, United States

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Los Angeles, California, 90048, United States

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Walnut Creek, California, 94598, United States

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Clermont, Florida, 34711, United States

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Gainesville, Florida, 32610, United States

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Tampa, Florida, 33606, United States

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Augusta, Georgia, 30912, United States

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Evergreen Park, Illinois, 60805, United States

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Hinsdale, Illinois, 60521, United States

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Baton Rouge, Louisiana, 70808, United States

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Osage Beach, Missouri, 65065, United States

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White Plains, New York, 10601, United States

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Canton, Ohio, 44718, United States

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Bethlehem, Pennsylvania, 18015, United States

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Philadelphia, Pennsylvania, 19141, United States

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Dallas, Texas, 75390-8567, United States

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Temple, Texas, 76508, United States

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Spokane, Washington, 99204, United States

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Garran, Australian Capital Territory, 2605, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Murdoch, Western Australia, 6150, Australia

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Sankt Pölten, Lower Austria, 3100, Austria

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Linz, Upper Austria, 4010, Austria

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Vienna, Vienna, 1090, Austria

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Brussels, Anderlecht, 1070, Belgium

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Bonheiden, Antwerp, 2820, Belgium

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Edegem, Antwerp, 2650, Belgium

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Leuven, Brabant, 3000, Belgium

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Liège, Wallonia, 4000, Belgium

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Stene, West Flanders, 8400, Belgium

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Curitiba, Paraná, 81480-580, Brazil

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Recife - PE, Recife - PE, 50070-490, Brazil

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

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Morumbi, São Paulo, 05651-901, Brazil

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São Paulo, 01246-000, Brazil

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São Paulo, 04538-132, Brazil

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Strasbourg, Alsace, 67000, France

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Grenoble, Auvergne-Rhône-Alpes, 38700, France

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St-Malo, Brittany Region, 35403, France

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Mulhouse, Grand Est, 68100, France

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

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Poitiers, Nouvelle-Aquitaine, 86000, France

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

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

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

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

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Heidenheim, Baden W Rttemberg, 89522, Germany

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Konstanz, Baden-Wurttemberg, 78484, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Schorndorf, Baden-Wurttemberg, 73614, Germany

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Stuttgart, Baden-Wurttemberg, 70174, Germany

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Augsburg, Bavaria, 86150, Germany

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Munich, Bavaria, 81377, Germany

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Bremenhaven, City state Bremen, 27574, Germany

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Kassel, Hesse, 34125, Germany

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Marburg, Hesse, 35033, Germany

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Wiesbaden, Hesse Land, 65189, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30161, Germany

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Hanover, Lower Saxony, 30459, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Bochum, North Rhine-Westphalia, 44892, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Moers, North Rhine-Westphalia, 47441, Germany

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Stolberg, North Rhine-Westphalia, 52222, Germany

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Koblenz, Rhineland-Palatinate, 56073, Germany

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Dresden, Saxony, 1307, Germany

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Leipzig, Saxony, 4103, Germany

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Halle, Saxony-Anhalt, 06108, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Neumünster, Schleswig-Holstein, 24534, Germany

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Berlin, 13353, Germany

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Hamburg, 20259, Germany

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Hamburg, 22291, Germany

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Chaïdári, Athens, 12462, Greece

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Athens, Attica, 11527, Greece

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Athens, Attica, 14564, Greece

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Thessaloniki, Central Macedonia, 54639, Greece

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Thessaloniki, Central Macedonia, 55236, Greece

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Larissa, Thessaly, 41110, Greece

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Nahariya, Northern Didstrict, 22100, Israel

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Ramat Gan, Tel Aviv, 52621, Israel

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Jerusalem, 9103102, Israel

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Tel Aviv, 6423906, Israel

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Naples, Campania, 80131, Italy

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Rome, Lazio, 00128, Italy

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Rome, Lazio, 00168, Italy

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Brescia, Lombardy, 25123, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20133, Italy

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Rozzano, Lombardy, 20089, Italy

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Turin, Piedmont, 10126, Italy

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Monserrato, Sardinia, 09042, Italy

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Pisa, Tuscany, 56124, Italy

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Nagoya, Aichi-ken, 466-8550, Japan

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Kashiwa-shi, Chiba, 277-8577, Japan

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Kurume, Fukuoka, 830-0011, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Yokohama, Kanagawa, 241-8515, Japan

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Kyoto, Kyoto, 606-8507, Japan

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Sendai, Miyagi, 980-8574, Japan

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Ōsaka-sayama, Osaka, 589-8511, Japan

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Lisbon, 1400 - 038, Portugal

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Lisbon, 1649-028, Portugal

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San Juan, Rio Piedras, 00935, Puerto Rico

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Bucharest, 22328, Romania

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Cluj-Napoca, 400162, Romania

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Iași, 700483, Romania

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Riyadh, Ar Riyadh, 12231, Saudi Arabia

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Jeddah, Mecca Region, 22384, Saudi Arabia

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Singapore, 329563, Singapore

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Santiago de Compostela, A Coruna, 15706, Spain

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Zaragoza, Aragon, 50009, Spain

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Santander, Cantabria, 39008, Spain

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Burgos, Castille and León, 9006, Spain

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Poniente Sur, Cordoba, 14004, Spain

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Ourense, Galicia, 32005, Spain

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El Palmar, Murcia, 30120, Spain

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Barcelona, 8035, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Oviedo, 33011, Spain

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Pamplona, 31008, Spain

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Santa Cruz de Tenerife, 38010, Spain

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Seville, 41009, Spain

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Valencia, 46010, Spain

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Zurich, 8032, Switzerland

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Kaohsiung City, 82445, Taiwan

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Taipei, 100225, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan, 33305, Taiwan

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

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Related Publications (1)

• 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.

  PMID: 41277677 DERIVED

MeSH Terms

Interventions

durvalumab

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 12, 2024
• Study Start: March 16, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.
• 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.

Locations

RO (3); BE (6); GR (6); FR (10); CH (1); ES (16); PR (1); AE (1); AU (4); JP (8); SG (1); DE (28); TW (4); BR (6); IL (4); IT (10); US (21); CA (1); PT (2); SA (2)