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

NCT07449637 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-1-9MS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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?

Conditions

BCLC Stage B Hepatocellular Carcinoma

Keywords

Intermediate-Stage Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• Overall Survival (OS)

  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)

  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)

  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)

  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.

Study Arms (1)

Patients with intermediate-stage hepatocellular carcinoma (BCLC-B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead
• Sohag Oncology Center: collaborator

Study Sites (1)

Sohag Oncology Center

Sohag, Sohag Governorate, Egypt

Location

Central Study Contacts

Mohammed Hamdy

CONTACT

+201101501551; mohammedzohry2018@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in Internal Medicine Department, Faculty of Medicine, Sohag University

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

EG (1)