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

NCT ID: NCT04234620

Last Updated: 2020-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-15

Study Completion Date

2023-07-05

Brief Summary

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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).

Detailed Description

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Conditions

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Melanoma Lung Cance Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Toripalimab injection

Use of Toripalimab injection in the real world

Toripalimab injection

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Cancer Hospital Chinese Academy of Medical Science

Beijing, , China

Site Status

The first affiliated Hospital of Jinlin Universtiy

Changchun, , China

Site Status

Hunan cancer hospital

Changsha, , China

Site Status

Xiangya Hospital Central South University

Changsha, , China

Site Status

Chongqing Haijiya Cancer Hospital

Chongqing, , China

Site Status

Fujian province cancer hospital

Fuzhou, , China

Site Status

Zhejiang cancer hospital

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

Qilu Hospital of Shandong university

Jinan, , China

Site Status

Shandong province cancer hospital

Jinan, , China

Site Status

Affiliated Cancer Hospital of Guangxi Medical university

Nanjing, , China

Site Status

Najing Drum Tower Hospital

Nanjing, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Shanxi Bethune Hopital

Shanxi, , China

Site Status

The fouth Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

The Second affiliated Hospital of Suzhou Universtiy

Suzhou, , China

Site Status

Tianjin Medical University cancer institute & Hospital

Tianjin, , China

Site Status

Hubei cancer hospital

Wuhan, , China

Site Status

Tongji Medical College of Huazhong University of Science & Technology

Wuhan, , China

Site Status

Wuhan Union Hospital

Wuhan, , China

Site Status

The first affiliated Hospital of Xiamen Universtiy

Xiamen, , China

Site Status

Yinchuan Lingke Internet Hosipital

Yinchuan, , China

Site Status

Affiliated Hopital of Guangdong Medical University

Zhanjiang, , China

Site Status

Henan cancer hospital

Zhengzhou, , China

Site Status

Countries

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China

Central Contacts

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jun guo, MD PhD

Role: CONTACT

8610-88121122

Facility Contacts

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jun guo

Role: primary

8610-88121122

Other Identifiers

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JS001-PMS-CO1

Identifier Type: -

Identifier Source: org_study_id

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