Real-World Treatment Patterns and Survival Outcomes in Patients With Intermediate-Stage Hepatocellular Carcinoma: An Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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?
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with intermediate-stage hepatocellular carcinoma (BCLC-B)
结局指标
主要结局
Overall Survival (OS)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Mohammed Hamdy Zohry
Resident in Internal Medicine Department, Faculty of Medicine, Sohag University
Sohag University