Observational Study Protocol: LIVER-R
Purpose
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).
Condition
- Hepatobiliary Cancers
Eligibility
- Eligible Ages
- Between 18 Years and 130 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| unresectable hepatocellular carcinoma (uHCC) | unresectable hepatocellular carcinoma (uHCC) |
|
| advanced biliary tract cancer (aBTC) | advanced biliary tract cancer (aBTC) |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233-1932
Mobile 4076598, Alabama 4829764 36604
Phoenix 5308655, Arizona 5551752 85004
Coronado 5339663, California 5332921 92118
Los Angeles 5368361, California 5332921 90048
Walnut Creek 5406990, California 5332921 94598
Clermont 4151352, Florida 4155751 34711
Gainesville 4156404, Florida 4155751 32610
Tampa 4174757, Florida 4155751 33606
Augusta 4180531, Georgia 4197000 30912
Evergreen Park 4891431, Illinois 4896861 60805
Hinsdale 4896012, Illinois 4896861 60521
Baton Rouge 4315588, Louisiana 4331987 70808
Osage Beach 4402040, Missouri 4398678 65065
White Plains 5144336, New York 5128638 10601
Canton 5149222, Ohio 5165418 44718
Bethlehem 5180225, Pennsylvania 6254927 18015
Philadelphia 4560349, Pennsylvania 6254927 19141
Dallas 4684888, Texas 4736286 75390-8567
Temple 4735966, Texas 4736286 76508
Spokane 5811696, Washington 5815135 99204
San Juan 4568127, Rio Piedras, Puerto Rico 00935
More Details
- NCT ID
- NCT06252753
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.