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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma; Breast Cancer; Lung Cance
• Intervention / Treatment: Drug: Toripalimab injection

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: jun guo, MD PhD; Phone Number: 8610-88121122; Email: guoj307@126.com

Study Locations

• China
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Science
  • Changchun, China
    • The first affiliated Hospital of Jinlin Universtiy
  • Changsha, China
    • Xiangya Hospital Central South University
  • Changsha, China
    • Hunan Cancer Hospital
  • Chongqing, China
    • Chongqing Haijiya Cancer Hospital
  • Fuzhou, China
    • Fujian Province Cancer Hospital
  • Hangzhou, China
    • Zhejiang Cancer Hospital
  • Harbin, China
    • Harbin Medical University Cancer Hospital
  • Jinan, China
    • Qilu Hospital of Shandong University
  • Jinan, China
    • Shandong Province Cancer Hospital
  • Nanjing, China
    • Affiliated Cancer Hospital of Guangxi Medical University
  • Nanjing, China
    • Najing Drum Tower Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shanxi, China
    • Shanxi Bethune Hopital
  • Shijiazhuang, China
    • The fouth Hospital of Hebei Medical University
  • Suzhou, China
    • The Second affiliated Hospital of Suzhou Universtiy
  • Tianjin, China
    • Tianjin Medical University Cancer Institute & Hospital
  • Wuhan, China
    • Hubei Cancer Hospital
  • Wuhan, China
    • Tongji Medical College of Huazhong University of Science & Technology
  • Wuhan, China
    • Wuhan Union Hospital
  • Xiamen, China
    • The first affiliated Hospital of Xiamen Universtiy
  • Yinchuan, China
    • Yinchuan Lingke Internet Hosipital
  • Zhanjiang, China
    • Affiliated Hopital of Guangdong Medical University
  • Zhengzhou, China
    • Henan Cancer Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: jun guo; Phone Number: 8610-88121122; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Toripalimab injection; Use of Toripalimab injection in the real world	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2020
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): July 5, 2023

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: JS001-PMS-CO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No