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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 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).

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 (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

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

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

Trial population

The study population includes patients treated with a durvalumab based regimen 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. Depending on the country, it is anticipated that 15 to 400 patients may be enrolled in each participating country.

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.

Treatment groups

4,490 Participants
are divided into 2 treatment groups
Group A: unresectable hepatocellular carcinoma (uHCC)1 intervention
Group B: advanced biliary tract cancer (aBTC)1 intervention

Trial outcomes

Primary outcomes

1

Real-world overall survival (rwOS)

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, 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.

Secondary outcomes

1

Real-world duration of treatment (rwDOT)

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

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

Real-world progression free survival (rwPFS)

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.

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.
3

Real-world time to progression (rwTTP)

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.

Time frame
rwTTP will be assessed as median TTP for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
4

Real-world time to next treatment (rwTTNT)

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

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

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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