Durvalumab-based combination therapies in observational study settingDurvalumab-based combination therapies in observational study settingNon Durvalumab-based therapies in observational study settingDurvalumab-based combination therapies in observational study settings
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).
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.
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.
Durvalumab-based combination therapies in observational study settings: Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected
Study 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 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 ).
Eligibility
Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Real-world overall survival (rwOS) in all participants — 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.
Trial sites (160)
Facility
City
Region
Status
Research Site
Birmingham
Alabama
Recruiting
Research Site
Mobile
Alabama
Recruiting
Research Site
Phoenix
Arizona
Recruiting
Research Site
Coronado
California
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Walnut Creek
California
Recruiting
Research Site
Clermont
Florida
Recruiting
Research Site
Gainesville
Florida
Recruiting
Research Site
Tampa
Florida
Recruiting
Research Site
Augusta
Georgia
Recruiting
Research Site
Evergreen Park
Illinois
Recruiting
Research Site
Hinsdale
Illinois
Recruiting
Research Site
Baton Rouge
Louisiana
Recruiting
Research Site
Boston
Massachusetts
Recruiting
Research Site
Osage Beach
Missouri
Recruiting
Research Site
White Plains
New York
Recruiting
Research Site
Canton
Ohio
Recruiting
Research Site
Bethlehem
Pennsylvania
Recruiting
Research Site
Lancaster
Pennsylvania
Recruiting
Research Site
Philadelphia
Pennsylvania
Recruiting
Research Site
Pittsburgh
Pennsylvania
Recruiting
Research Site
Dallas
Texas
Recruiting
Research Site
Temple
Texas
Recruiting
Research Site
Spokane
Washington
Recruiting
Research Site
Garran
Australian Capital Territory
Recruiting
Research Site
Heidelberg
Victoria
Recruiting
Research Site
Melbourne
Victoria
Recruiting
Research Site
Murdoch
Western Australia
Recruiting
Research Site
Sankt Pölten
Lower Austria
Recruiting
Research Site
Vienna
State of Vienna
Recruiting
Research Site
Linz
Upper Austria
Recruiting
Research Site
Brussels
Anderlecht
Recruiting
Research Site
Bonheiden
Antwerp
Recruiting
Research Site
Edegem
Antwerp
Recruiting
Research Site
Leuven
Brabant
Recruiting
Research Site
Liège
Wallonia
Recruiting
Research Site
Stene
West Flanders
Recruiting
Research Site
Curitiba
Paraná
Recruiting
Research Site
Recife - PE
Recife - PE
Recruiting
Research Site
Porto Alegre
Rio Grande do Sul
Recruiting
+ 120 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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