October 22, 2025Open Access

Real-world outcomes and predictive factors in hepatocellular carcinoma patients treated with sorafenib: an 18-month ambispective cohort analysis

MNMahmoud NazihUniversity of Sadat City AKAhmed I. KhoderUniversity of Sadat City IWImam WakedMiddle East Liver Disease Center

Key Points

Overall survival rates at 6, 12, and 18 months are 69.3%, 45.2%, and 31.1%, respectively, indicating gradual decline in treatment efficacy.
Prognostic factors such as ECOG performance status ≥ 1 and AFP > 400 ng/mL significantly correlate with reduced overall survival, highlighting critical metrics for clinicians.
An ambispective cohort study analysed 347 patients over 18 months, integrating retrospective and prospective data to assess the effectiveness of sorafenib.
Identifying poor prognostic factors early may lead to optimized treatment outcomes and better management of toxicity in real-world settings.

Abstract

Abstract Background Hepatocellular carcinoma (HCC) represents 90% of primary liver cancers and is the fourth leading cause of cancer-related death worldwide. Sorafenib remains the standard first-line systemic therapy for advanced HCC, though real-world outcomes vary from clinical trial results. We aimed to evaluate survival outcomes and identify prognostic factors in HCC patients receiving sorafenib in routine clinical practice over an 18-month follow-up period in a real-world clinical setting. Methods An ambispective cohort study (integrating retrospective and prospective data) was conducted involving 347 patients with confirmed primary HCC treated with Sorafenib between June 2023 and January 2025, of whom 292 had complete 18-month follow-up and were included in the survival analysis . Clinical data, laboratory markers, imaging Response Evaluation Criteria In Solid Tumors (RECIST 1.1), adverse effects, and treatment modifications were analyzed. Kaplan–Meier analysis and Cox regression models were used to determine overall survival (OS), progression-free survival (PFS), and prognostic predictors. Results The observed OS rates at 6, 12, and 18 months were 69.3%, 45.2%, and 31.1%, respectively. Corresponding PFS rates were 58.6%, 36.9%, and 24.8%. In multivariate analysis, Eastern Cooperative Oncology Group (ECOG) performance status ≥ 1, AFP > 400 ng/mL, Albumin-Bilirubin (ALBI) grade 3, and vascular invasion were significantly associated with reduced OS ( p < 0.05). Patients who achieved partial response or stable disease per RECIST were more likely to continue Sorafenib beyond 6 months. Toxicity was generally tolerable, with a low rate of permanent treatment discontinuation. Conclusion Sorafenib continues to demonstrate efficacy in real-world practice as first-line therapy for advanced HCC, with clear clinical and biochemical indicators, including ALBI grade, AFP, ECOG, and early radiological response, serving as key prognostic factors of treatment success. Early response assessment with identification of poor prognostic factors is critical for optimizing outcomes, and proactive toxicity management can improve outcomes in real-world settings.

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