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Observational Study Protocol: LIVER-R

Description

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).

Conditions

Hepatobiliary Cancers
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Related Conditions:

Hepatobiliary Cancers

Study Overview

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Study Details

Study overview

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).

An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers

Observational Study Protocol: LIVER-R

Condition
Hepatobiliary Cancers
Intervention / Treatment

-

Contacts and Locations

Phoenix

Research Site, Phoenix, Arizona, United States, 85004

Coronado

Research Site, Coronado, California, United States, 92118

Gainesville

Research Site, Gainesville, Florida, United States, 32610

Augusta

Research Site, Augusta, Georgia, United States, 30912

Hinsdale

Research Site, Hinsdale, Illinois, United States, 60521

White Plains

Research Site, White Plains, New York, United States, 10601

Canton

Research Site, Canton, Ohio, United States, 44718

Bethlehem

Research Site, Bethlehem, Pennsylvania, United States, 18015

Dallas

Research Site, Dallas, Texas, United States, 75390-8567

Temple

Research Site, Temple, Texas, United States, 76508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2030-12-30