Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Overall Survival (OS)
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Patients with intermediate-stage hepatocellular carcinoma (BCLC-B)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed Hamdy Zohry
Resident in Internal Medicine Department, Faculty of Medicine, Sohag University
Sohag University