Observational Study Protocol: LIVER-R

Active:	Yes
Cancer Type:		NCT ID:	NCT06252753
Trial Phases:		Protocol IDs:	D419CR00035 (primary) NCI-2024-05517
Eligibility:	18 - 130 Years, Male and Female	Study Type:	Other
Study Sponsor:	AstraZeneca Pharmaceuticals LP
NCI Full Details:	http://clinicaltrials.gov/show/NCT06252753

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).

Objectives

LIVER-R is a real-world, multi-country, multi-centre study aiming to enroll approximately
4,000 patients across hepatobiliary cohorts (approximately 1,385 patients for aBTC,
approximately 1,165 patients for uHCC, approximately 1,000 patients for eeHCC, and
approximately 400 patients for EMERALD) across multiple 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 or without 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 or non durvalumab-based regimen) and a follow-up
period to the earliest of death, loss to follow-up, withdrawal, or end of study for a
minimum follow-up of 2 years. 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.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

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