Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .

Study Overview
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Brief Summary
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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).

Official Title
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A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.

Conditions
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Melanoma, Lung Cance, Breast Cancer

Intervention / Treatment
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* Drug: Toripalimab injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Toripalimab injection<br>Use of Toripalimab injection in the real world | Drug: Toripalimab injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | the incidence of all adverse events (AE); the incidence of different severity AE; | 3 years | 
| SAE | The incidence of severe adverse events (SAE): | 3 years | 
| Immune-related AE. | The incidence, severity of immune-related adverse events; | 3 years | 
| 1 -, 2 -, 3-year OS rate. | Survival indicators: overall survival (OS); 1 -, 2 -, 3-year OS rate. | 3 years |