A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 主要终点
- Real-world Progression-Free Survival (rwPFS)
研究概览
简要总结
This is a prospective, observational, multi-center, real-world study evaluating the effectiveness and safety of Toripalimab (a PD-1 inhibitor) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The primary objective is to assess real-world progression-free survival (rwPFS). Secondary objectives include evaluating real-world objective response rate (rwORR), disease control rate (rwDCR), overall survival (rwOS), and safety. Approximately 1200 patients from multiple centers in China will be enrolled and followed according to routine clinical practice. Data will be collected from medical records and follow-up visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign the informed consent form.
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC);
- •Scheduled to receive Toripalimab as first-line treatment;
- •Availability of traceable medical history records during the treatment period.
排除标准
- •Pregnant or lactating women;
- •Known allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components；
- •Any other condition deemed by the investigator as unsuitable for inclusion in the study.
研究组 & 干预措施
Toripalimab group
干预措施: Toripalimab (Drug)
结局指标
主要结局
Real-world Progression-Free Survival (rwPFS)
时间窗: 2 years
The time from the initiation of the first dose until the first documented occurrence of disease progression or death from any cause, whichever occurs first. Patients who do not experience any event during follow-up or study treatment will be censored at the time of their last tumor assessment. Patients who do not have any post-baseline assessment will be censored on the date of enrollment/initiation of medication.
次要结局
- Real-world Overall Survival (rwOS)(2 years)
- Real-world Objective Response Rate (rwORR)(2 years)
- Real-world Disease Control Rate (rwDCR)(2 years)
- Treatment-related adverse event (TRAE)(2 years)