Observational Study Protocol: LIVER-R

Recruiting now

Conditions studied: Hepatobiliary Cancers

In brief

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).

Key facts

Study ID

NCT06252753

Run by

AstraZeneca

People needed

4490

Starts

2023-12-20

Expected to finish

2030-12-30

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Mobile, Alabama, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — Coronado, California, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — Walnut Creek, California, United States (enrolling)
• Research Site — Clermont, Florida, United States (enrolling)
• Research Site — Gainesville, Florida, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Augusta, Georgia, United States (enrolling)
• Research Site — Evergreen Park, Illinois, United States (enrolling)
• Research Site — Hinsdale, Illinois, United States (enrolling)
• Research Site — Baton Rouge, Louisiana, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Osage Beach, Missouri, United States (enrolling)
• Research Site — White Plains, New York, United States (enrolling)
• Research Site — Canton, Ohio, United States (enrolling)
• Research Site — Bethlehem, Pennsylvania, United States (enrolling)
• Research Site — Lancaster, Pennsylvania, United States (enrolling)
• Research Site — Philadelphia, Pennsylvania, United States (enrolling)
• Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
• Research Site — Dallas, Texas, United States (enrolling)
• Research Site — Temple, Texas, United States (enrolling)
• Research Site — Spokane, Washington, United States (enrolling)
• Research Site — Garran, Australian Capital Territory, Australia (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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