A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
Overview
- Phase
- Not Applicable
- Intervention
- Toripalimab injection
- Conditions
- Melanoma
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 800
- Locations
- 25
- Primary Endpoint
- SADR
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
Toripalimab injection
Use of Toripalimab injection in the real world
Intervention: Toripalimab injection
Outcomes
Primary Outcomes
SADR
Time Frame: 3 years
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
The incidence of all ADR.
Time Frame: 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.
Time Frame: 3 years
The incidence of known adverse reactions ((ADR)).
The incidence of adverse drug reactions ((ADR)) in special populations.
Time Frame: 3 years
The occurrence of new adverse reactions ((ADR)
Time Frame: 3 years
The occurrence of new adverse reactions ((ADR)).
Immune-related ADR
Time Frame: 3 years
The incidence, severity and risk factors of immune-related adverse reactions.
Secondary Outcomes
- AE(3 years)
- SAE(3 years)
- Immune-related AE.(3 years)
- 1 -, 2 -, 3-year OS rate.(3 years)