Clinical trial NCT04234620: Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
Official title: A Prospective, Single-arm, Multicenter, Non-interventional Real-world Study of Toripalimab Injection in the Treatment of Malignant Tumors in Chinese Population.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Lung Cance
Breast Cancer
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: Inclusion Criteria:

1. Patients with approved indications of Toripalimab injection;
2. Patients treated with Toripalimab injection;
3. Patients who agreed to participate in this study and signed an informed consent form.

Exclusion Criteria:

1. Refused to participate or refused to cooperate with the procedure;
2. 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.

Primary outcomes:
measure: The incidence of all ADR.
timeFrame: 3 years
measure: known ADR.
timeFrame: 3 years
measure: The occurrence of new adverse reactions ((ADR)
timeFrame: 3 years
measure: SADR
timeFrame: 3 years
measure: Immune-related ADR
timeFrame: 3 years
measure: The incidence of adverse drug reactions ((ADR)) in special populations.
timeFrame: 3 years
Secondary outcomes:
measure: AE
timeFrame: 3 years
measure: SAE
timeFrame: 3 years
measure: Immune-related AE.
timeFrame: 3 years
measure: 1 -, 2 -, 3-year OS rate.
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
city: Changchun
country: China
facility: The first affiliated Hospital of Jinlin Universtiy
city: Changsha
country: China
facility: Hunan cancer hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chongqing
country: China
facility: Chongqing Haijiya Cancer Hospital
city: Fuzhou
country: China
facility: Fujian province cancer hospital
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong university
city: Jinan
country: China
facility: Shandong province cancer hospital
city: Nanjing
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical university
city: Nanjing
country: China
facility: Najing Drum Tower Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanxi
country: China
facility: Shanxi Bethune Hopital
city: Shijiazhuang
country: China
facility: The fouth Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The Second affiliated Hospital of Suzhou Universtiy
city: Tianjin
country: China
facility: Tianjin Medical University cancer institute & Hospital
city: Wuhan
country: China
facility: Hubei cancer hospital
city: Wuhan
country: China
facility: Tongji Medical College of Huazhong University of Science & Technology
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Xiamen
country: China
facility: The first affiliated Hospital of Xiamen Universtiy
city: Yinchuan
country: China
facility: Yinchuan Lingke Internet Hosipital
city: Zhanjiang
country: China
facility: Affiliated Hopital of Guangdong Medical University
city: Zhengzhou
country: China
facility: Henan cancer hospital
Study officials:
References: