Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.

Aim of work:

• To evaluate real-world treatment patterns and survival outcomes among patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at a tertiary care center.

Study Design:

• Observational cohort study.

Study Setting:

• Single-center study at Sohag Oncology Center.

Study Period:

• 01 January 2020 - 31 December 2025.

Sample Size:

• Expected cohort: 120-300 patients.
• Adequate for survival analysis and multivariable modeling in real-world studies.

Data Collection

• Baseline Characteristics:

• Age, sex
• Etiology of liver disease (HBV, HCV, MASH, …)
• AFP level
• Child-Pugh score
• ALBI grade
• Tumor burden (number, size of largest lesion, bilobar involvement)
• Treatment Variables

• Type of initial therapy
• Number of TACE sessions
• Time to TACE refractoriness
• Use of systemic therapy (Tyrosine Kinase inhibitors, Immunotherapy, combinations)
• Treatment sequencing

Statistical analysis:

• Statistical analysis will be performed by SPSS 24.0 software (SPSS, Inc., Chicago, IL).
• Descriptive statistics for baseline characteristics.
• Kaplan-Meier survival curves for OS and PFS.
• Log-rank test for group comparisons.
• Multivariable Cox proportional hazards regression to identify predictors of survival.
• Subgroup analyses:

• Up-to-7 in vs out.
• Child-Pugh A vs B.
• TACE-only vs sequential/systemic.

Study Objectives:

• Primary Objective

• To estimate overall survival (OS) among patients with intermediate-stage HCC receiving real-world treatment.
• Secondary Objectives

• To describe real-world treatment patterns (First-line, subsequent lines, combination therapies) and time to treatment changes.
• To estimate progression-free survival (PFS) and time to treatment failure (TTF) by treatment group.
• To evaluate safety signals (hospitalizations for treatment-related complications) in each treatment group.
• To identify predictors of survival, including:

• Tumor burden.
• Child-Pugh class.
• Laboratory markers (AFP, Bilirubin, Albumin).

Inclusion criteria

• Aged ≥18 years.
• Both sexes.
• Diagnosis of hepatocellular carcinoma based on accepted radiologic or histologic criteria.
• Classified as intermediate stage (BCLC-B) at time of decision for first-line treatment.
• Child-Pugh A or B.
• ECOG performance status 0-1.

Exclusion criteria

• BCLC A, C, or D at diagnosis.
• Prior curative therapy (resection, transplantation, curative ablation).
• Missing essential data (imaging, liver function, treatment records).
• Mixed HCC-cholangiocarcinoma.