OREIOS International Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |