OREIOS International Study (OREIOS)

A Multicountry, Multicentre, Noninterventional, Retrospective Study to Describe the Real-world Management Outcomes in Patients With Unresectable Hepatocellular Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma

Detailed Description

Patients with unresectable HCC are an extremely heterogeneous population, with several coexisting risk factors like underlying hepatic dysfunction, extrahepatic metastases, and macrovascular invasion (MVI) posing a challenge for optimum sequencing of the existing, newly approved, and emerging targeted therapies. Real-world studies have identified factors such as performance status, Child-Pugh class, MVI or extrahepatic metastasis and AFP levels, which predict the response to treatment. More than half of patients with HCC present with intermediate or advanced-stage disease (BCLC stage B, C or D) and require palliative care. Very few studies have identified the predictors of survival in advanced HCC and further exploration is warranted to optimize treatment regimen. Systemic therapy based on multi-kinase inhibitors, anti-angiogenesis agents, and immunotherapy have become the cornerstone of advanced HCC management. Despite these advances, patients with HCC still have a poor long-term prognosis of -12 month. Clinical decision making has become challenging in cases with localized but unresectable disease or in the presence of impaired liver function; there are multiple treatment options and selection between them is not supported by direct comparative evidence. Furthermore, disease and patient characteristics seen in clinical practice may be very different from those included in clinical trials; there may be less rigorous follow up and patient counselling resulting in reduced compliance with treatments. 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 multi-country, multicenter, 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.

• Study Type: Observational
• Enrollment (Actual): 1127

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 1246000
    • Research site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90560030
      • Research site
• Egypt
  • Alexandira, Egypt
    • Research site
  • Assiut, Egypt
    • Research site
  • Cairo, Egypt
    • Research site
  • Menufia, Egypt
    • Research site
• Hong Kong
  • Hong Kong, Hong Kong
    • Research site
• India
  • Faridabad, India
    • Research site
  • Howrah, India
    • Research site
  • Kolkata, India
    • Research site
  • New Delhi, India
    • Research site
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Research site
• Kuwait
  • Kuwait, Kuwait
    • Research site
• Oman
  • Muscat, Oman
    • Research site
• Russian Federation
  • Chelyabinsk, Russian Federation
    • Research site
  • Moscow, Russian Federation
    • Research site
  • Saint Petersburg, Russian Federation
    • Research site
• Saudi Arabia
  • Makkah, Saudi Arabia
    • Research site
  • Riyadh, Saudi Arabia
    • Research site
• Singapore
  • Singapore, Singapore
    • Research site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Research site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. 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
2. 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.
3. 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.
4. 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.

Exclusion Criteria:

1. Patients with BCLC stage D HCC at index diagnosis
2. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the management patterns in patients with unresectable HCC	Percentage of patients receiving standard regimens alone or in combination with other systemic agents in each line of therapy (LOT)	through study completion, an average of 2 year
To describe the demographic and clinical characteristics of patients with unresectable HCC	Demographic and clinical characteristics of patients with unresectable HCC	At baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the survival outcomes associated with different treatment regimens for unresectable HCC	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)	Effectiveness of 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 disease control rate (rwDCR)	Effectiveness of different treatment regimens for unresectable HCC	through study completion, an average of 2 year
To investigate the correlation between survival outcomes and clinical characteristics, liver function, and underlying disease in unresectable HCC	Identification of potential factors correlating with OS (median OS) among the following clinico-pathological variables:	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR_Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 12, 2023
• Study Completion (Actual): March 12, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: D419CR00025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No