Use of Immune Checkpoint Inhibitors in Patients With Advanced Hepatocellular Carcinoma : Efficacy and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- ICI-Specific Survival (OS-ICI).
研究概览
简要总结
the Objectives of this study are:
• Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors.
the main question it aims to answer is: What are the clinical outcomes (overall survival, progression-free survival, and OS-ICIs) of immune checkpoint inhibitor therapy in patients with advanced hepatocellular carcinoma? Participants already taking immune checkpoint inhibitors as part of their regular medical care.
详细描述
Objectives • Primary Objective: To prospectively evaluate overall survival (OS), ICI-specific survival (OS-ICI), and progression-free survival (PFS) in patients with advanced HCC treated with immune checkpoint inhibitors.
• Secondary Objectives: To assess the incidence, type, and severity of irAEs. To identify clinical predictors of survival outcomes, including ALBI grade, prior LRT, SBRT or resection.
To guide personalized therapy for Tailoring immunotherapy to individual patients, reducing unnecessary toxicity and cost.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (≥18 years) with radiologically or histologically confirmed advanced HCC
- •Candidates for systemic immune checkpoint inhibitors (e.g., atezolizumab-bevacizumab, durvalumab-tremelimumab).
- •Patients with preserved liver function. ( up to G2 using ALBI score or up to B (7 ) using Child-Pugh socring system) .
排除标准
- •Child-Pugh C liver function.
- •Prior liver transplantation.
- •patients with concurrent malignancies other than HCC.
- •Active autoimmune disease requiring systemic immunosuppression.
研究组 & 干预措施
all patients diagnosed with advanced hepatocellular carcinoma eligible for ICIs
结局指标
主要结局
ICI-Specific Survival (OS-ICI).
时间窗: 12 months
Time from ICI initiation to death or last follow-up.
次要结局
未报告次要终点
研究者
Ahmed Karam Helmy
Use of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma : efficacy and outcomes
Sohag University