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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06252753




Registration number
NCT06252753
Ethics application status
Date submitted
21/12/2023
Date registered
12/02/2024

Titles & IDs
Public title
Observational Study Protocol: LIVER-R
Scientific title
An Observational Multi Center Study to Evaluate Real World Treatment Outcomes of Durvalumab Based Regimens in Hepatobiliary Cancers
Secondary ID [1] 0 0
D419CR00035
Universal Trial Number (UTN)
Trial acronym
LIVER-R
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary Cancers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Durvalumab-based combination therapies in observational study setting
Other interventions - Durvalumab-based combination therapies in observational study setting

unresectable hepatocellular carcinoma (uHCC) - unresectable hepatocellular carcinoma (uHCC)

advanced biliary tract cancer (aBTC) - advanced biliary tract cancer (aBTC)


Other interventions: Durvalumab-based combination therapies in observational study setting
Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

Other interventions: Durvalumab-based combination therapies in observational study setting
Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Real-world overall survival (rwOS)
Timepoint [1] 0 0
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 outcome [1] 0 0
Real-world duration of treatment (rwDOT)
Timepoint [1] 0 0
rwDOT will be assessed as median DOT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Secondary outcome [2] 0 0
Real-world progression free survival (rwPFS)
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Real-world time to progression (rwTTP)
Timepoint [3] 0 0
rwTTP will be assessed as median TTP for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Secondary outcome [4] 0 0
Real-world time to next treatment (rwTTNT)
Timepoint [4] 0 0
rwTTNT will be assessed as median TTNT for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Secondary outcome [5] 0 0
Real-world recurrence free survival (rwRFS)
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Real-world time to recurrence (rwTTR)
Timepoint [6] 0 0
rwTTR will be assessed as median TTR for a maximum follow-up of 2 years (aBTC) or 3 years (uHCC).
Secondary outcome [7] 0 0
Patient demographic and clinical characteristics
Timepoint [7] 0 0
Patient demographic and clinical characteristics will be captured up to 5 years prior to the index date.
Secondary outcome [8] 0 0
Percentage of patients receiving each treatment regimen
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Clinically significant events (CSEs) of interest leading to a medical intervention
Timepoint [9] 0 0
CSEs will be captured from the index date through 90 days after the last administration of durvalumab-based regimen or death, whichever occurs first.

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2030
Actual
Sample size
Target
4490
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
Research Site - Garran
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
'2605 - Garran
Recruitment postcode(s) [2] 0 0
'3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Austria
State/province [10] 0 0
Upper Austria
Country [11] 0 0
Brazil
State/province [11] 0 0
Parana
Country [12] 0 0
Brazil
State/province [12] 0 0
Rio Grande Do Sul
Country [13] 0 0
France
State/province [13] 0 0
Alsace
Country [14] 0 0
France
State/province [14] 0 0
Auvergne-Rh ne-Alpes
Country [15] 0 0
France
State/province [15] 0 0
Bretagne
Country [16] 0 0
France
State/province [16] 0 0
Grand Est
Country [17] 0 0
France
State/province [17] 0 0
Hauts-de-France
Country [18] 0 0
France
State/province [18] 0 0
Ile-de-France
Country [19] 0 0
France
State/province [19] 0 0
Nouvelle-Aquitaine
Country [20] 0 0
France
State/province [20] 0 0
Provence-Alpes-Cote d'Azur
Country [21] 0 0
Germany
State/province [21] 0 0
Baden W Rttemberg
Country [22] 0 0
Germany
State/province [22] 0 0
Baden-W Rttemberg
Country [23] 0 0
Germany
State/province [23] 0 0
Bavaria
Country [24] 0 0
Germany
State/province [24] 0 0
Hesse
Country [25] 0 0
Germany
State/province [25] 0 0
Lower Saxony
Country [26] 0 0
Germany
State/province [26] 0 0
North Rhine-Westphalia
Country [27] 0 0
Germany
State/province [27] 0 0
Rhineland-Palatinate
Country [28] 0 0
Germany
State/province [28] 0 0
Saxony-Anhalt
Country [29] 0 0
Germany
State/province [29] 0 0
Saxony
Country [30] 0 0
Germany
State/province [30] 0 0
Schleswig-Holstein
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Greece
State/province [33] 0 0
Athens
Country [34] 0 0
Greece
State/province [34] 0 0
Attica
Country [35] 0 0
Greece
State/province [35] 0 0
Central Macedonia
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaly
Country [37] 0 0
Italy
State/province [37] 0 0
Campania
Country [38] 0 0
Italy
State/province [38] 0 0
Lazio
Country [39] 0 0
Italy
State/province [39] 0 0
Lombardy
Country [40] 0 0
Italy
State/province [40] 0 0
Piemonte
Country [41] 0 0
Italy
State/province [41] 0 0
Tuscany
Country [42] 0 0
Japan
State/province [42] 0 0
Aichi-Ken
Country [43] 0 0
Japan
State/province [43] 0 0
Chiba
Country [44] 0 0
Japan
State/province [44] 0 0
Ishikawa
Country [45] 0 0
Japan
State/province [45] 0 0
Kanagawa
Country [46] 0 0
Puerto Rico
State/province [46] 0 0
San Juan
Country [47] 0 0
Singapore
State/province [47] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ICON plc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Plan to share only the redacted CSR synopsis

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06252753