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Massive global study tracks Durvalumab's Real-World impact on liver cancers

NCT ID NCT06252753

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This study will follow about 4,490 adults with liver or bile duct cancer who are receiving durvalumab-based treatment as part of their routine care. Researchers want to see how long patients live and how well the treatment works outside of clinical trials. The goal is to gather real-world data to improve future treatment decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

biliary tract cancer hepatobiliary neoplasm hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatobiliary cancers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    159 sites in 22 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

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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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    Boston, Massachusetts, 02215, 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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    Lancaster, Pennsylvania, 17604, United States

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    Philadelphia, Pennsylvania, 19141, United States

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    Pittsburgh, Pennsylvania, 15212, 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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    Vienna, State of Vienna, 1090, Austria

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    Linz, Upper Austria, 4010, 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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    Calgary, Alberta, T2N 4N2, Canada

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    Edmonton, Alberta, T6G-1Z2, Canada

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    Halifax, Nova Scotia, B3H 2Y9, Canada

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    London, Ontario, N6A 5W9, Canada

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    Strasbourg, Alsace, 67000, France

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    Grenoble, Auvergne-Rh ne-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, New 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-W Rttemberg, 78484, Germany

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    Mannheim, Baden-W Rttemberg, 68167, Germany

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    Schorndorf, Baden-Wurttemberg, 73614, Germany

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    Stuttgart, Baden-Wurttemberg, 70174, Germany

  • Research Site

    TERMINATED

    Augsburg, Bavaria, 86150, Germany

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    Munich, Bavaria, 81377, Germany

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    Bremenhaven, Free Hanseatic City of 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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    Rostock, Mecklenburg-Vorpommern, 18057, 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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    Cologne, North Rhine-Westphalia, 50937, 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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    Zwickau, Saxony, 8060, 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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    Berlin, 14165, Germany

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    Bremen, 28211, 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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    Bergen, Hordaland, 5021, Norway

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    Oslo, Ostlandet, 379, Norway

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    Vila Real, North, 5000-508, Portugal

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    Faro, 8000-386, Portugal

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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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    Craiova, 200347, 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, 169610, Singapore

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    Singapore, 329563, Singapore

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    Santiago de Compostela, A Coru A, 15706, Spain

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    Zaragoza, Aragon, 50009, Spain

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    Poniente Sur, C Rdoba, 14004, Spain

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    Santander, Cantabria, 39008, Spain

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    Burgos, Castile-Le N, 9006, Spain

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    Ourense, Galicia, 32005, Spain

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    Majadahonda, Madrid, 28222, 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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    Madrid, 28041, 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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    Lausanne, Canton of Vaud, 1005, Switzerland

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    Zurich, 8032, Switzerland

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    Taichung, Taichung City, 40705, Taiwan

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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 City, 33305, Taiwan

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

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    Deira, Dubai, 7272, United Arab Emirates

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