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临床试验/NCT04996459
NCT04996459Unknown不适用

Real-world Study of Tislelizumab in the Systematic Treatment of Advanced Hepatocellular Carcinoma

Fudan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月1日最近更新:
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:

  1. Age ≥18 years old;
  2. Unresectable hepatocellular carcinoma confirmed by histological examination or clinical diagnosis;
  3. Plan or have received systemic therapy combined with Tiralizumab;
  4. No participation in other clinical studies;
  5. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lu Wang, MD, PhD

Head of liver surgery department

Fudan University

研究点 (1)

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