RECRUITING

Observational Study Protocol: LIVER-R

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-12-20
Study Completion:2030-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06252753

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.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years and a lawful adult in the country at the index date
  2. 2. Confirmed presence of malignancy of primary hepatobiliary cancer (i.e., uHCC or aBTC) by the treating physician
  3. 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. 4. Informed consent was obtained as per country level regulations on or after the index date
  1. 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. 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. 3. Received a liver transplant during the baseline period

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85004
United States
Research Site
Coronado, California, 92118
United States
Research Site
Gainesville, Florida, 32610
United States
Research Site
Augusta, Georgia, 30912
United States
Research Site
Hinsdale, Illinois, 60521
United States
Research Site
White Plains, New York, 10601
United States
Research Site
Canton, Ohio, 44718
United States
Research Site
Bethlehem, Pennsylvania, 18015
United States
Research Site
Dallas, Texas, 75390-8567
United States
Research Site
Temple, Texas, 76508
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20
Study Completion Date2030-12-30

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2030-12-30

Terms related to this study

Keywords Provided by Researchers

  • Hepatobiliary cancer
  • Unresectable hepatocellular carcinoma (uHCC)
  • Advanced biliary tract cancer (aBTC)
  • Durvalumab
  • Observatory
  • Real-world

Additional Relevant MeSH Terms

  • Hepatobiliary Cancers