Follow-up Registration Management of Anti-angiogenesis Combined With PD-1/PD-L1 Therapy in Patients With Advanced Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 490
- 主要终点
- Progression-Free Survival
研究概览
简要总结
To observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people.
详细描述
This project is a non-interventional, prospective, multicenter, case follow-up registry management, aiming to observe and explore the effect of anti-angiogenesis combined with PD-1/PD-L1 therapy in the real world on the survival prognosis of patients with advanced liver cancer, and to summarize the treatment experience of a wide range of people. Therefore, the data collected and reported in this project will reflect the actual efficacy and safety of anti-angiogenesis combined with PD-1/PD-L1 therapy in patients with advanced liver cancer. 490 patients are planned for follow-up, and enrollment is expected for this program to last for 2 years, starting in December 2021 and ending with the last patient enrollment in December 2023. The treatment period was 24 months, and the patient follow-up was 24 months after the last patient was enrolled.
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
- •Age: ≥ 18 years old, male or female;
- •Patients diagnosed with advanced liver cancer, including barcelona stage B, C or Chinese liver cancer guidelines stage IIa, IIb, IIIa, IIIb liver cancer patients;
- •doctors evaluate patients who can benefit from anti-angiogenesis targeted therapy;
- •patients voluntarily join the program and sign informed consent.
- •Exclusion criteria:
- •The above selection criteria are not met
排除标准
- 未提供
结局指标
主要结局
Progression-Free Survival
时间窗: 3-4 weeks
Progression-free survival (PFS) is defined as the time from random assignment in a clinical trial to disease progression or death from any cause.
次要结局
- Objective Response Rate(3-4 weeks)
- Overall survival(3-4 weeks)
- disease control rate(3-4 weeks)