BCLC Stage B Hepatocellular Carcinoma
Conditions
Keywords
Intermediate-Stage Hepatocellular Carcinoma
Brief 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).
Interventions
None listed
Sponsors
Sohag University
Sohag Oncology Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization to the end of treatment at 5 years. | Overall survival (OS) is defined as the time from randomization to death. |
| Progression-Free Survival (PFS) | From randomization to the end of treatment at 5 years. | Progression-free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death. |
| Objective response (mRECIST) | From randomization to the end of treatment at 5 years. | According to mRECIST for HCC, CR is the disappearance of any intratumoral arterial enhancement in all target lesions. PR is at least a 30% decrease in the sum of the diameters of viable (contrast enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of the target lesions. Overall response is a result of the combined assessment of target lesions, nontarget lesions and new lesions. |
| Adverse events (CTCAE) | From randomization to the end of treatment at 5 years. | An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. This definition is standardized by the Common Terminology Criteria for Adverse Events (CTCAE) system to ensure consistent reporting and grading of toxicity severity across studies. |
Countries
Egypt
Contacts
CONTACTMohammed Hamdy
Outcome results
None listed