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

February 27, 2026 updated by: Mohammed Hamdy Zohry, Sohag University

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

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?

Study Overview

Status

Not yet recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate-stage hepatocellular carcinoma (BCLC-B) treated at Sohag Oncology Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with intermediate-stage hepatocellular carcinoma (BCLC-B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to the end of treatment at 5 years.
Overall survival (OS) is defined as the time from randomization to death.
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.
Progression-free survival (PFS) is defined as the time from randomization until first evidence of disease progression or death.
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.
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.
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.
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.
From randomization to the end of treatment at 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Sohag Oncology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med-26-1-9MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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