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

Shanghai Junshi Biosciences

Status

Unknown

Conditions

Breast Cancer

Melanoma

Lung Cance

Treatments

Drug: Toripalimab injection

Study type

Observational

Funder types

Other

Identifiers

NCT04234620

JS001-PMS-CO1

Details and patient eligibility

About

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).

Enrollment

800 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.