OREIOS International Study

Hepatocellular Carcinoma Clinical Trial

— OREIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239507
• Other study ID #: D419CR00025
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: March 12, 2023

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1127
• Est. completion date: March 12, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Egypt,  Hong Kong,  India,  Korea, Republic of,  Kuwait,  Oman,  Russian Federation,  Saudi Arabia,  Singapore,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	To describe the demographic and clinical characteristics of patients with unresectable HCC	Demographic and clinical characteristics of patients with unresectable HCC	At baseline

External Links

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