LIVER-R study protocol: a global real-world study of durvalumab-based regimens in patients with hepatobiliary cancers.
Journal
Future oncology (London, England)
Journal Volume
21
Journal Issue
29
Start Page
3739
End Page
3748
ISSN
1744-8301
Date Issued
2025-12
Author(s)
Ikeda, Masafumi
Wörns, Marcus-Alexander
Akce, Mehmet
Tebbutt, Niall C
Casadei-Gardini, Andrea
Sah, Janvi
Farid-Kapadia, Mufiza
Stirnadel-Farrant, Heide A
Paskow, Michael J
Baur, Boris
Melillo, Giovanni
Schmidt, James
Daktera, Anna
Knox, Jennifer J
Abstract
Durvalumab-based regimens have improved outcomes compared with standard of care in unresectable hepatocellular carcinoma (uHCC) and advanced biliary tract cancer (aBTC) clinical trials. Here we describe the protocol for the LIVER-R study, which will evaluate long-term outcomes with durvalumab-based regimens in patients with hepatobiliary cancers in real-world settings.
LIVER-R (NCT06252753) is an observational study aiming to initially enroll ~2500 adults with uHCC or aBTC from ~179 sites in 22 countries. Patients treated with durvalumab-based regimens as part of routine clinical practice or a global early access program will be included. The primary outcome is overall survival. Secondary outcomes include duration of treatment, progression-free survival, treatment patterns and safety. Data will be collected at baseline and every 6 months. The study will include a baseline period of up to 5 years before index date (initiation of first-line durvalumab-based regimen) and a follow-up period from index until death, loss to follow-up, withdrawal, or study end. Study variables will be analyzed descriptively; time-to-event outcomes will be analyzed using the Kaplan-Meier method.
LIVER-R will produce a large, global, real-world standardized dataset of patients with uHCC or aBTC treated with a durvalumab-based regimen, providing insights into real-world clinical practice.
www.clinicaltrials.gov identifier is NCT06252753.
Hepatocellular carcinoma (HCC) is a type of liver cancer and a leading cause of cancer-related death. Most people with HCC present with a disease that is not treatable by surgery, called unresectable HCC (uHCC). Biliary tract cancers (BTCs) are a group of tumors in the bile ducts and gallbladder. BTCs that are not treatable by surgery are known as advanced BTC (aBTC). Durvalumab is a type of immunotherapy and durvalumab-based treatments were found to be effective for patients with uHCC and aBTC in previous clinical trials. The LIVER-R study will look at how well durvalumab-based treatments work in patients with uHCC or aBTC in day-to-day clinical practice.This real-world study aims to enroll approximately 2500 people with uHCC or aBTC globally. Data from patients will be collected as part of routine clinical practice or gathered from patient medical charts every 6 months. The main objective of this study is to measure the length of time that people live after receiving durvalumab-based treatments. Secondary outcomes include the length of time from the start of treatment to when a patient’s cancer worsened or led to death, treatment patterns, and negative side effects experienced during the study period.This study is still ongoing. More information about this study can be found at https://clinicaltrials.gov/study/NCT06252753.
Subjects
Advanced biliary tract cancer
durvalumab
real-world
tremelimumab
unresectable hepatocellular carcinoma
Type
journal article