NCT04996459Unknown不适用
Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Study purpose: To evaluate the efficacy and safety of Tislelizumab in combination with advanced hepatocellular carcinoma in the real world; Study design: Non-intervention, single center, case registration, real-world study; Number of registrations: 40;
Source of data: This project is a non-interventionary real world case follow-up registration. All registration data are from real clinical practice cases. The collected data include the following requirements:
- Age ≥18 years old;
- Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
- Plan or have received systemic therapy combined with Tiralizumab;
- No participation in other clinical studies;
- Access to Tislelizumab treatment and other clinical records; Primary endpoint: Overall response rate; Secondary endpoint: Disease control rate, progress free survival, overall survival, safety; Exploratory endpoint: To explore the predictive value of multiple Biomarker combinations, such as PD-L1, TMB, MSI, DDR, POLE/POLD, in HCC immunotherapy response.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tislelizumab group
干预措施: Tislelizumab (Drug)
结局指标
主要结局
overall response rate
时间窗: 6 weeks
overall response rate
次要结局
- overall survival(6 weeks)
- disease control rate(6 weeks)
- progress free survival(6 weeks)
- Safety (the incidence of adverse events and serious adverse events)(3 weeks)
研究者
Lu Wang, MD, PhD
Head of liver surgery department
Fudan University
研究点 (1)
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