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 Criteria:

  1. 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:

  1. 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

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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Page 1 of 35 (138 locations)

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

Observational Study Protocol: LIVER-R | DecenTrialz