Trial Title:
Observational Study Protocol: LIVER-R
NCT ID:
NCT06252753
Condition:
Hepatobiliary Cancers
Conditions: Official terms:
Durvalumab
Antibodies, Monoclonal
Conditions: Keywords:
Hepatobiliary cancer
Unresectable hepatocellular carcinoma (uHCC)
Advanced biliary tract cancer (aBTC)
Durvalumab
Observatory
Real-world
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Durvalumab-based combination therapies in observational study setting
Description:
Data on patients who initiated durvalumab-based regimens, including STRIDE (Single
Tremelimumab Regular Interval Durvalumab), will be collected).
Arm group label:
unresectable hepatocellular carcinoma (uHCC)
Other name:
Imfinzi
Intervention type:
Other
Intervention name:
Durvalumab-based combination therapies in observational study setting
Description:
Data on patients who initiated durvalumab-based regimens, including durvalumab +
chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.
Arm group label:
advanced biliary tract cancer (aBTC)
Other name:
Imfinzi
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).
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-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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Phoenix
Zip:
85004
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Coronado
Zip:
92118
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
White Plains
Zip:
10601
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75390-8567
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Temple
Zip:
76508
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Linz
Zip:
4010
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90035-001
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Strasbourg
Zip:
67000
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grenoble
Zip:
38700
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
St Malo
Zip:
35403
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mulhouse
Zip:
68100
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75012
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Poitiers
Zip:
86000
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Avignon
Zip:
84918
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Marseille
Zip:
13008
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heidenheim
Zip:
89522
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Augsburg
Zip:
86150
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Marburg
Zip:
35033
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Goettingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30161
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hannover
Zip:
30459
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Aachen
Zip:
52074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bochum
Zip:
44892
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dortmund
Zip:
44137
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moers
Zip:
47441
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Stolberg
Zip:
52222
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koblenz
Zip:
56073
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Halle (Saale)
Zip:
6108
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Neumuenster
Zip:
24534
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
20259
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hamburg
Zip:
22291
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chaidari
Zip:
12462
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Athens
Zip:
11527
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Athens
Zip:
14564
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Thessaloniki
Zip:
54639
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Thessaloniki
Zip:
55236
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Larissa
Zip:
41110
Country:
Greece
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Naples
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rome
Zip:
00128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Turin
Zip:
10126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pisa
Zip:
56124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya
Zip:
466-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kanazawa-shi
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Juan
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Zip:
329563
Country:
Singapore
Status:
Recruiting
Start date:
December 20, 2023
Completion date:
December 13, 2029
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
ICON plc
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06252753
