Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
- Conditions
- MelanomaLung CanceBreast Cancer
- Interventions
- Registration Number
- NCT04234620
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Toripalimab injection Toripalimab injection Use of Toripalimab injection in the real world
- Primary Outcome Measures
Name Time Method SADR 3 years The incidence, severity and risk factors of severe adverse reactions ((SADR)).
The incidence of all ADR. 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. 3 years The incidence of known adverse reactions ((ADR)).
The incidence of adverse drug reactions ((ADR)) in special populations. 3 years The occurrence of new adverse reactions ((ADR) 3 years The occurrence of new adverse reactions ((ADR)).
Immune-related ADR 3 years The incidence, severity and risk factors of immune-related adverse reactions.
- Secondary Outcome Measures
Name Time Method AE 3 years 1. the incidence of all adverse events (AE);
2. the incidence of different severity AE;SAE 3 years The incidence of severe adverse events (SAE):
Immune-related AE. 3 years The incidence, severity of immune-related adverse events;
1 -, 2 -, 3-year OS rate. 3 years Survival indicators: overall survival (OS); 1 -, 2 -, 3-year OS rate.
Trial Locations
- Locations (25)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Science
🇨🇳Beijing, China
Hunan cancer hospital
🇨🇳Changsha, China
The first affiliated Hospital of Jinlin Universtiy
🇨🇳Changchun, China
Xiangya Hospital Central South University
🇨🇳Changsha, China
Chongqing Haijiya Cancer Hospital
🇨🇳Chongqing, China
Fujian province cancer hospital
🇨🇳Fuzhou, China
Zhejiang cancer hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Qilu Hospital of Shandong university
🇨🇳Jinan, China
Shandong province cancer hospital
🇨🇳Jinan, China
Najing Drum Tower Hospital
🇨🇳Nanjing, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Shanxi Bethune Hopital
🇨🇳Shanxi, China
The fouth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Tianjin Medical University cancer institute & Hospital
🇨🇳Tianjin, China
The Second affiliated Hospital of Suzhou Universtiy
🇨🇳Suzhou, China
Hubei cancer hospital
🇨🇳Wuhan, China
Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, China
Wuhan Union Hospital
🇨🇳Wuhan, China
The first affiliated Hospital of Xiamen Universtiy
🇨🇳Xiamen, China
Yinchuan Lingke Internet Hosipital
🇨🇳Yinchuan, China
Affiliated Hopital of Guangdong Medical University
🇨🇳Zhanjiang, China
Henan cancer hospital
🇨🇳Zhengzhou, China
Affiliated Cancer Hospital of Guangxi Medical university
🇨🇳Nanjing, China