Health Trials

Observational Study Protocol: LIVER-R

ConditionHepatobiliary Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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 multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without 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 regimens (durvalumab-based or otherwise) 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, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and a lawful adult in the country at the index date

Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)

Decision to treat was made independently and prior to obtaining informed consent

Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)

Disqualifiers

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

Second primary malignancy prior to HCC or BTC diagnosis

Received a liver transplant during the baseline period

Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible

Trial population

The study population includes patients treated with durvalumab-based and non durvalumab-based regimens for hepatobiliary cancer as part of routine clinical practice. The decision to treat patients with a durvalumab based regimen should be independent from the decision to enroll patients in the study.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Durvalumab-based combination therapies in observational study setting

    Other intervention

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

  • Durvalumab-based combination therapies in observational study setting

    Other intervention

    Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

  • Non Durvalumab-based therapies in observational study setting

    Other intervention

    Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.

  • Durvalumab-based combination therapies in observational study settings

    Other intervention

    Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected

Treatment groups

4,000 Participants
are divided into 4 treatment groups
Group A: unresectable hepatocellular carcinoma (uHCC)1 intervention
Group B: advanced biliary tract cancer (aBTC)1 intervention
Group C: eeHCC1 intervention
Group D: EMERALD1 intervention

Trial outcomes

Primary outcomes

1

Real-world overall survival (rwOS) in all participants

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

Time frame
rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years.

Secondary outcomes

1

Clinically significant events (CSEs) of interest leading to a medical intervention in all participants

CSEs of interest leading to medical intervention including 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.

Time frame
CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based or non durvalumab-based regimens or death, whichever occurs first.
2

Patient demographic and clinical characteristics in all participants

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

Time frame
Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.
3

Characterize the durvalumab-based regimen and/or LRT treatment patterns in all participants

Treatment patterns of the index durvalumab-based regimen or LRT will be described. Treatment patterns of therapies administered both before and after the first administration of index durvalumab-based regimen or LRT will be described.

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 minimum follow-up of 2 years.
4

Real-world duration of treatment (rwDOT) in all participants

rwDOT will be calculated as the time from the index date to date of discontinuation of the index durvalumab-based regimen or LRT.

Time frame
rwDOT will be assessed as event rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median DOT for a minimum follow-up of 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

ICON plc

Collaborator

Source ClinicalTrials.gov
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