Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: BCLC Stage B Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.
Overview
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).
Primary outcome measures
- Overall Survival (OS) [Time frame: From randomization to the end of treatment at 5 years.]
- Progression-Free Survival (PFS) [Time frame: From randomization to the end of treatment at 5 years.]
- Objective response (mRECIST) [Time frame: From randomization to the end of treatment at 5 years.]
- Adverse events (CTCAE) [Time frame: From randomization to the end of treatment at 5 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Sohag Oncology Center — Sohag
Identifiers
NCT: NCT07449637 · Soh-Med-26-1-9MS