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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04234620
• Other study ID #: JS001-PMS-CO1
• Status: Not yet recruiting
• Start date: February 15, 2020
• Est. completion date: July 5, 2023

Study information

• Verified date: January 2020
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: jun guo, MD PhD
• Phone: 8610-88121122
• Email: guoj307[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: July 5, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cance
• Melanoma

Intervention

Drug:
• Toripalimab injection
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	known ADR.	The incidence of known adverse reactions ((ADR)).	3 years
Primary	The occurrence of new adverse reactions ((ADR)	The occurrence of new adverse reactions ((ADR)).	3 years
Primary	SADR	The incidence, severity and risk factors of severe adverse reactions ((SADR)).	3 years
Primary	Immune-related ADR	The incidence, severity and risk factors of immune-related adverse reactions.	3 years
Primary	The incidence of adverse drug reactions ((ADR)) in special populations.		3 years
Secondary	AE	the incidence of all adverse events (AE); the incidence of different severity AE;	3 years
Secondary	SAE	The incidence of severe adverse events (SAE):	3 years
Secondary	Immune-related AE.	The incidence, severity of immune-related adverse events;	3 years
Secondary	1 -, 2 -, 3-year OS rate.	Survival indicators: overall survival (OS); 1 -, 2 -, 3-year OS rate.	3 years