Real-world registry of patients with unresectable hepatocellular carcinoma: The OREIOS study.

TPS618 Background: A majority of patients with hepatocellular carcinoma (HCC) are diagnosed with unresectable disease due to extensive extrahepatic spread, presence of multifocal tumors, poor hepatic function or tumor location near major intrahepatic vessels. The treatment landscape for unresectable HCC is rapidly evolving with availability of novel agents, mandating evidence-based therapeutic algorithm for optimum clinical outcomes. Integrating newly approved and emerging therapies in this extremely heterogeneous HCC population with coexisting risk factors (performance status, Child-Pugh class, macrovascular invasion or extrahepatic metastases, and alpha-fetoprotein levels) may pose challenge without understanding survival outcomes with the current treatment practices. Also, application of immunotherapy and targeted agents in clinical practice displays significant regional variations. Real-world evidence on the management of unresectable HCC is sparse across different geographies. The OREIOS study aims to describe the management patterns, clinical characteristics, possible predictors, and survival outcomes in patients with unresectable HCC in 12 countries across Asia, Latin America and the Middle East. The data may serve in devising policies on optimal patient selection and sequencing of novel systemic therapies for unresectable HCC. Methods: OREIOS is an ongoing multicenter, retrospective, non-interventional registry in adults diagnosed between 01 January 2017 and 31 December 2019 with unresectable BCLC stage B HCC, ineligible for initial loco-regional therapy or stage C advanced or metastatic disease, with at least 12 months (or until death if it occurs within 12 months of diagnosis) of available records. Patients with BCLC stage D and other concomitant metastatic cancers are excluded. Data collection includes socio-demographics, clinico-pathological characteristics, treatment modalities, survival outcomes, comorbidities and liver function status. Primary outcome measures include median overall survival using the Kaplan–Meier method and survival rates at 6, 12, 18 and 24 months. Secondary outcomes include clinico-demographic characteristics, treatment regimens (alone or combination) in each line of therapy and real-world progression-free survival. Additionally, prognostic and predictive factors for survival outcomes will be evaluated. Of the planned sample size of 1440 patients, a total of 473 patients with unresectable HCC have been enrolled until August 2022 across 7 countries (Egypt: 105, Hong Kong: 107, India: 79, Russia: 100, Saudi Arabia: 27, Singapore: 50, South Korea: 05). Data collection is currently ongoing and results are expected by 2024. Clinical trial information: NCT05239507 .