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NCT Number: NCT06252753

Observational Study Protocol: LIVER-R

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).

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Key information

Conditions

Hepatobiliary Cancers

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Garran, Australian Capital Territory, Australia

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About this study

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=1355) across 22 countries from North and South America, Europe, the Middle East and the Asia-Pacific region. The study design will include primary and secondary data collection. Primary data will be collected in real-time during the patient's routine visit. Secondary data will be collected from the patient's medical record at enrollment and at prespecified study time points (6-month intervals). The study population includes adult patients whose physician has previously made the decision to treat them with a durvalumab-based regimen for hepatobiliary cancer as part of routine clinical practice or patients receiving treatment through EAP. The study will include a baseline period of up to 5 years before the index date (initiation of a Durvalumab-based regimen) and a follow-up period to the earliest of death, loss to follow-up, withdrawal, or end of study for a maximum follow-up of 2 years for patients with aBTCs or 3 years for patients with uHCC. This is a descriptive, noncomparative study. No formal hypotheses are to be tested. All descriptive analyses will be conducted separately for each primary hepatobiliary cancer indication. Kaplan Meier estimates will be produced for time-to-event outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Durvalumab-based combination therapies in observational study setting

Other

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

Other names: Imfinzi

Primary outcomes

  1. Real-world overall survival (rwOS)

    Time frame: rwOS will be assessed as OS rates at 6, 12, 24 months (both aBTC and uHCC), and 36 months (uHCC), median OS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.

    rwOS will be calculated as the time from the index date to date of death, by any cause.

Secondary outcomes

  1. Real-world duration of treatment (rwDOT)

    Time frame: rwDOT will be assessed as median DOT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).

    rwDOT will be calculated for each systemic treatment as the time from the index date to date of discontinuation for any reason.

  2. Real-world progression free survival (rwPFS)

    Time frame: rwPFS will be assessed as PFS rates at 6, 12, 24 months (both aBTC and uHCC), and 36 months (uHCC), median PFS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.

    rwPFS will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment or death, whichever is earlier.

  3. Real-world time to progression (rwTTP)

    Time frame: rwTTP will be assessed as median TTP for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).

    rwTTP will be calculated as the time from the index date to the date of documented disease progression as determined by the physician's assessment.

  4. Real-world time to next treatment (rwTTNT)

    Time frame: rwTTNT will be assessed as median TTNT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).

    rwTTNT will be calculated as the time from the index date to the date of initiation of the next treatment.

  5. Real-world recurrence free survival (rwRFS)

    Time frame: rwRFS will be assessed as RFS rates at 6, 12, 24 months (both aBTC and uHCC), and 36 months (uHCC), median RFS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively.

    rwRFS will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment or death, whichever is earlier. The analysis will be performed in patients who underwent curative therapy (resection or ablation).

  6. Real-world time to recurrence (rwTTR)

    Time frame: rwTTR will be assessed as median TTR for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).

    rwTTR will be defined as the time from the index date to the date of documented disease recurrence as determined by the physician's assessment. The analysis will be performed in patients who underwent curative therapy (resection or ablation).

  7. Patient demographic and clinical characteristics

    Time frame: Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.

    Descriptive statistics will be used to describe demographic and clinical characteristics for the enrolled patients.

  8. Percentage of patients receiving each treatment regimen

    Time frame: Treatment patterns will be captured from the index date until the earliest of death, loss to follow-up, withdrawal, or end of study for a maximum follow-up of 2 years for patients with aBTCs or 3 years for patients with uHCC.

    Treatment patterns will be calculated from the index date until death, loss to follow-up, withdrawal from the study, or end of the study, whichever is earliest.

  9. Clinically significant events (CSEs) of interest leading to a medical intervention

    Time frame: CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based regimen or death, whichever occurs first.

    CSEs of interest leading to medical intervention including durvalumab based treatment interruption, discontinuation, hospitalization, or which require interventions of concomitant use of corticosteroids, immunosuppressants and/or endocrine therapies will be captured for the enrolled patients.

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • ICON plc

Registry information

Official study title

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

Acronym: LIVER-R

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Feb 12, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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