OREIOS International Study
OREIOS
A Multicountry, Multicentre, Noninterventional, Retrospective Study to Describe the Real-world Management Outcomes in Patients With Unresectable Hepatocellular Carcinoma
1 other identifier
observational
1,127
11 countries
21
Brief Summary
Considering the treatment landscape with its dynamic algorithms and new approaches of sequencing, it is important to identify patient management patterns and survival outcomes arising from the current standard of care. Based on all these considerations, this multicountry, multicentre, noninterventional, real-world, retrospective study is designed to describe the management patterns, clinical characteristics, possible predictors, and survival outcomes in patients with unresectable HCC. The results of this study might help oncologists in optimal patient selection and sequencing of the systemic therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2023
CompletedMarch 13, 2024
March 1, 2024
1.1 years
November 30, 2021
March 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To describe the OS rate in patients with unresectable HCC including estimates of survival rates at 6, 12, and 18 months and at 2 years
OS Kaplan-Meier (KM) curve and survival rates at 6, 12, and 18 months and at 2 years
Change from Baseline in Survival Rates at 2 years
Secondary Outcomes (2)
To describe the management patterns in patients with unresectable HCC
through study completion, an average of 2 year
To describe the demographic and clinical characteristics of patients with unresectable HCC
At baseline
Other Outcomes (4)
To describe the survival outcomes associated with different treatment regimens for unresectable HCC
through study completion, an average of 2 year
To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world objective response rate (rwORR)
through study completion, an average of 2 year
To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world disease control rate (rwDCR)
through study completion, an average of 2 year
- +1 more other outcomes
Eligibility Criteria
The study population will include patients diagnosed with unresectable HCC, who have been treated or are currently receiving treatment outside North America and Europe. Participating countries will include Brazil, Hong Kong, Oman, Kuwait, Qatar, South Korea, Russia, UAE, Saudi Arabia, Egypt, India, and Taiwan.
You may qualify if:
- Adult female or male patients aged ≥18 years or 'adults' according to the age of majority as defined by the local regulations at index diagnosis
- Patients or legal representative (unless a waiver is granted) willing and be able to provide informed consent according to local regulations. For deceased patients at study entry, informed consent is not mandatory.
- Patients with radiologically or histopathologically confirmed diagnosis (at index date) of unresectable BCLC stage B HCC, not considered eligible for initial loco-regional therapya or stage C advanced or metastatic disease, between 01 January 2017 and 31 December 2019.
- Availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis.
You may not qualify if:
- Patients with BCLC stage D HCC at index diagnosis
- Patients with concomitant cancer, at the time of diagnosis of unresectable HCC, except for the nonmetastatic nonmelanoma skin cancers or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HCC diagnosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Porto Alegre, Rio Grande do Sul, 90560030, Brazil
Research Site
São Paulo, 1246000, Brazil
Research Site
Alexandira, Egypt
Research Site
Asyut, Egypt
Research Site
Cairo, Egypt
Research Site
Menufia, Egypt
Research Site
Hong Kong, Hong Kong
Research Site
Faridabad, India
Research Site
Howrah, India
Research Site
Kolkata, India
Research Site
New Delhi, India
Research Site
Kuwait City, Kuwait
Research Site
Muscat, Oman
Research Site
Chelyabinsk, Russia
Research Site
Moscow, Russia
Research Site
Saint Petersburg, Russia
Research Site
Mecca, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Singapore, Singapore
Research Site
Seoul, South Korea
Research Site
Abu Dhabi, United Arab Emirates
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
February 15, 2022
Study Start
February 1, 2022
Primary Completion
March 12, 2023
Study Completion
March 12, 2023
Last Updated
March 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.