A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 25
- 主要终点
- SADR
研究概览
简要总结
This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with previously systemic failure . The study population currently included only in the melanoma cohort-unresectable or metastatic melanoma patients who had previously failed systemic therapy. If new indications are approved during the implementation of the project, patients with new indications using Toripalimab injection will also be included in this study as a new cohort.This study uses offline (physical hospital) and online (DTP pharmacy and Lingke (Yinchuan) Internet hospital) to collect data and information, relying on Lingke technology (Beijing) Co., Ltd. EDC (Medical Research Cloud) database for data collection and processing. The classification of adverse events was based on the general toxicity evaluation standard NCI CTCAE 5.0 of the National Institute of Oncology (Chinese version).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with approved indications of Toripalimab injection;
- •Patients treated with Toripalimab injection;
- •Patients who agreed to participate in this study and signed an informed consent form.
排除标准
- •Refused to participate or refused to cooperate with the procedure;
- •Those who participated in the intervention study of other unapproved drugs / therapies and less than 5 half-lives after the last use of the study drugs.
研究组 & 干预措施
Toripalimab injection
Use of Toripalimab injection in the real world
干预措施: Toripalimab injection (Drug)
结局指标
主要结局
SADR
时间窗: 3 years
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
The incidence of all ADR.
时间窗: 3 years
the incidence of all ADR: the number and percentage of patients with ADR, and the number of ADR events will be summarized according to the International Medical Dictionary (MedDRA) preferred terminology and adverse events General terminology Standard (NCI CTCAE5.0 Chinese version). Any ADR collected during the study will be included in the ADR summary.
known ADR.
时间窗: 3 years
The incidence of known adverse reactions ((ADR)).
The incidence of adverse drug reactions ((ADR)) in special populations.
时间窗: 3 years
The occurrence of new adverse reactions ((ADR)
时间窗: 3 years
The occurrence of new adverse reactions ((ADR)).
Immune-related ADR
时间窗: 3 years
The incidence, severity and risk factors of immune-related adverse reactions.
次要结局
- AE(3 years)
- SAE(3 years)
- Immune-related AE.(3 years)
- 1 -, 2 -, 3-year OS rate.(3 years)