Clinical trial NCT05239507: OREIOS International Study
Official title: A Multicountry, Multicentre, Noninterventional, Retrospective Study to Describe the Real-world Management Outcomes in Patients With Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-02-15
Enrollment: 1127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Change from Baseline in Survival Rates at 2 years
Secondary outcomes:
measure: To describe the management patterns in patients with unresectable HCC
timeFrame: through study completion, an average of 2 year
measure: To describe the demographic and clinical characteristics of patients with unresectable HCC
timeFrame: At baseline
Other outcomes:
measure: To describe the survival outcomes associated with different treatment regimens for unresectable HCC
timeFrame: through study completion, an average of 2 year
measure: To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world objective response rate (rwORR)
timeFrame: through study completion, an average of 2 year
measure: To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world disease control rate (rwDCR)
timeFrame: through study completion, an average of 2 year
measure: To investigate the correlation between survival outcomes and clinical characteristics, liver function, and underlying disease in unresectable HCC
timeFrame: through study completion, an average of 2 year
Locations:
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Research Site
city: Alexandira
country: Egypt
facility: Research Site
city: Assiut
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Menufia
country: Egypt
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Faridabad
country: India
facility: Research Site
city: Howrah
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kuwait
country: Kuwait
facility: Research Site
city: Muscat
country: Oman
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Makkah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
Study officials:
References: