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.
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 Type
OBSERVATIONAL
Enrollment
1,127
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
São Paulo, Brazil
Research Site
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
Time frame: Change from Baseline in Survival Rates at 2 years
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)
Time frame: 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
Time frame: At baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alexandira, Egypt
Research Site
Asyut, Egypt
Research Site
Cairo, Egypt
Research Site
Menufia, Egypt
Research Site
Hong Kong, Hong Kong
Research Site
Faridabad, India
Research Site
Howrah, India
Research Site
Kolkata, India
...and 11 more locations