Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
1 other identifier
observational
800
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2020
CompletedFirst Posted
Study publicly available on registry
January 21, 2020
CompletedStudy Start
First participant enrolled
February 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedJanuary 21, 2020
January 1, 2020
3 years
January 16, 2020
January 17, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
The incidence of all ADR.
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.
3 years
known ADR.
The incidence of known adverse reactions ((ADR)).
3 years
The occurrence of new adverse reactions ((ADR)
The occurrence of new adverse reactions ((ADR)).
3 years
SADR
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
3 years
Immune-related ADR
The incidence, severity and risk factors of immune-related adverse reactions.
3 years
The incidence of adverse drug reactions ((ADR)) in special populations.
3 years
Secondary Outcomes (4)
AE
3 years
SAE
3 years
Immune-related AE.
3 years
1 -, 2 -, 3-year OS rate.
3 years
Study Arms (1)
Toripalimab injection
Use of Toripalimab injection in the real world
Interventions
240 mg/6 mL/vial. The recommended dose of Toripalima is 3 mg/kg, intravenous infusion every 2 weeks until disease progression or intolerable toxicity.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
The first affiliated Hospital of Jinlin Universtiy
Changchun, China
Hunan cancer hospital
Changsha, 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
Affiliated Cancer Hospital of Guangxi Medical university
Nanjing, 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
The Second affiliated Hospital of Suzhou Universtiy
Suzhou, China
Tianjin Medical University cancer institute & Hospital
Tianjin, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2020
First Posted
January 21, 2020
Study Start
February 15, 2020
Primary Completion
February 1, 2023
Study Completion
July 5, 2023
Last Updated
January 21, 2020
Record last verified: 2020-01