A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall survival(OS)
研究概览
简要总结
Our project is going to clarify the efficacy and safety of Toripalimab in lung cancer in the real world, and to evaluate the incidence of adverse events (AEs) of special interest during Toripalimab immunotherapy.
详细描述
Tumor immunotherapy, as another important treatment after surgical treatment, chemoradiotherapy and targeted therapy, has achieved great success and gradually become one of the standard treatment methods for tumors. Toripalimab is the first Chinese PD-1 inhibitor approved for the treatment of nasopharyngeal carcinoma, malignant melanoma, urothelial carcinoma, esophageal squamous cell carcinoma and non-small cell lung cancer. It has been widely used in clinical practice. Several clinical studies have confirmed that it is safe and effective. In recent years, several clinical studies have reported that Toripalimab alone or in combination can improve the response rate of cancer treatment and improve survival. The results of Toripalimab research are mainly derived from rigorously designed randomized controlled trials (RCTs), and the efficacy and safety in the real world still need to be further explored. Real world studies, based on a large sample size, non-randomly select treatment measures according to the actual condition and wishes of patients, and pay attention to meaningful outcome treatment, which is closer to real clinical practice, without extrapolation difficulties, and has more clinical practical value. Therefore, it is of great significance to carry out a real-world study to investigate the differences in the efficacy and adverse reactions of Toripalimab immunotherapy in Chinese lung cancer patients in order to better guide clinical practice, which also provides research direction and data support for further prospective studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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.
- •Cytologically or histologically confirmed lung cancer.
- •Complete clinical data.
- •Indications for immunotherapy with Toripalimab.
排除标准
- •Lack of patient key data.
- •Refusal or uncooperation with the study.
研究组 & 干预措施
Immunotherapy Regimen
Patients receiving different treatment regimens of Toripalimab in each center were consecutively enrolled from January 1, 2019 to December 31, 2022
干预措施: Toripalimab (Drug)
结局指标
主要结局
Overall survival(OS)
时间窗: 2 years
OS was calculated from the date of randomization to death from any cause.
次要结局
- Progression Free Survival(PFS)(2 years)
- Overall Response Rate (ORR)(1 year)
- Disease Control Rate(DCR)(1 year)
- Health-related quality of life (HRQoL)(Within 1 year after starting Toripalimab treatment)
研究者
Jiandong Zhang
Qianfoshan Hospital
Qianfoshan Hospital
