OREIOS International Study
Study Details
Study Description
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
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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 Design
Outcome Measures
Primary Outcome Measures
- 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 [Change from Baseline in Survival Rates at 2 years]
OS Kaplan-Meier (KM) curve and survival rates at 6, 12, and 18 months and at 2 years
Secondary Outcome Measures
- To describe the management patterns in patients with unresectable HCC [through study completion, an average of 2 year]
Percentage of patients receiving standard regimens alone or in combination with other systemic agents in each line of therapy (LOT)
- To describe the demographic and clinical characteristics of patients with unresectable HCC [At baseline]
Demographic and clinical characteristics of patients with unresectable HCC
Other Outcome Measures
- To describe the survival outcomes associated with different treatment regimens for unresectable HCC [through study completion, an average of 2 year]
Survival outcomes associated with different treatment regimens for unresectable HCC
- 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]
Effectiveness of different treatment regimens for unresectable HCC
- 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]
Effectiveness of different treatment regimens for unresectable HCC
- To investigate the correlation between survival outcomes and clinical characteristics, liver function, and underlying disease in unresectable HCC [through study completion, an average of 2 year]
Identification of potential factors correlating with OS (median OS) among the following clinico-pathological variables:
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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.
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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.
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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:
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Patients with BCLC stage D HCC at index diagnosis
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Alexandira | Egypt | ||
| 2 | Research Site | Cairo | Egypt | ||
| 3 | Research Site | Menufia | Egypt | ||
| 4 | Research Site | Faridabad | India | ||
| 5 | Research Site | Howrah | India | ||
| 6 | Research Site | Kolkata | India | ||
| 7 | Research Site | Kolkata | India | ||
| 8 | Research Site | Mumbai | India | ||
| 9 | Research Site | New Delhi | India | ||
| 10 | Research Site | Chelyabinsk | Russian Federation | ||
| 11 | Research Site | Moscow | Russian Federation | ||
| 12 | Research Site | Moscow | Russian Federation | ||
| 13 | Research Site | Saint Petersburg | Russian Federation | ||
| 14 | Research Site | Makkah | Saudi Arabia |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D419CR00025