NCT07449637

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

Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the different treatment options for intermediate-stage hepatocellular carcinoma. The main question it aims to answer is: \- What are the survival outcomes among participants aged 18 or older who receive treatment for intermediate-stage hepatocellular carcinoma?

Detailed description

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 1. 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) 2. 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: 1. Primary Objective \- To estimate overall survival (OS) among patients with intermediate-stage HCC receiving real-world treatment. 2. 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).

Conditions

• BCLC Stage B Hepatocellular Carcinoma

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: Egypt