跳至主要内容
临床试验/NCT05652712
NCT05652712招募中不适用

A Real-World Study of Toripalimab in Chinese Patients With Lung Cancer(THUNDER Study)

Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1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
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

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

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiandong Zhang

Qianfoshan Hospital

Qianfoshan Hospital

研究点 (1)

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