Status:
RECRUITING
Observational Study Protocol: LIVER-R
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
ICON plc
Conditions:
Hepatobiliary Cancers
Eligibility:
All Genders
18-130 years
Brief 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 indica...
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...
Eligibility Criteria
Inclusion
- Age ≥18 years and a lawful adult in the country at the index date
- Confirmed presence of malignancy of primary hepatobiliary cancer (i.e., uHCC or aBTC) by the treating physician
- 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
- Informed consent was obtained as per country level regulations on or after the index date
Exclusion
- 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
- 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)
- Received a liver transplant during the baseline period
Key Trial Info
Start Date :
March 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
4490 Patients enrolled
Trial Details
Trial ID
NCT06252753
Start Date
March 16 2023
End Date
December 30 2030
Last Update
December 26 2025
Active Locations (138)
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1
Research Site
Birmingham, Alabama, United States, 35233-1932
2
Research Site
Mobile, Alabama, United States, 36604
3
Research Site
Phoenix, Arizona, United States, 85004
4
Research Site
Coronado, California, United States, 92118