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 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).

Objectives

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.

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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