- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234620
Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
January 17, 2020 updated by: Shanghai Junshi Bioscience Co., Ltd.
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
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: jun guo, MD PhD
- Phone Number: 8610-88121122
- Email: guoj307@126.com
Study Locations
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Toripalimab injection
Use of Toripalimab injection in the real world
|
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.
Time Frame: 3 years
|
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.
Time Frame: 3 years
|
The incidence of known adverse reactions ((ADR)).
|
3 years
|
The occurrence of new adverse reactions ((ADR)
Time Frame: 3 years
|
The occurrence of new adverse reactions ((ADR)).
|
3 years
|
SADR
Time Frame: 3 years
|
The incidence, severity and risk factors of severe adverse reactions ((SADR)).
|
3 years
|
Immune-related ADR
Time Frame: 3 years
|
The incidence, severity and risk factors of immune-related adverse reactions.
|
3 years
|
The incidence of adverse drug reactions ((ADR)) in special populations.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AE
Time Frame: 3 years
|
|
3 years
|
SAE
Time Frame: 3 years
|
The incidence of severe adverse events (SAE):
|
3 years
|
Immune-related AE.
Time Frame: 3 years
|
The incidence, severity of immune-related adverse events;
|
3 years
|
1 -, 2 -, 3-year OS rate.
Time Frame: 3 years
|
Survival indicators: overall survival (OS); 1 -, 2 -, 3-year OS rate.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on Toripalimab injection
-
Mabwell (Shanghai) Bioscience Co., Ltd.Not yet recruitingAdvanced Urothelial CarcinomaChina
-
Shanghai Junshi Bioscience Co., Ltd.RecruitingLimited-stage Small Cell Lung Cancer (LS-SCLC)China, Taiwan, Georgia, United States
-
RemeGen Co., Ltd.RecruitingAdvanced Solid TumorChina
-
Abbisko Therapeutics Co, LtdEnrolling by invitationTriple Negative Breast CancerChina
-
Nanjing Leads Biolabs Co.,LtdRecruitingAdvanced Solid TumorChina
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
Beijing Friendship HospitalNot yet recruiting
-
Ascentage Pharma Group Inc.Recruiting
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingAdvanced Hepatocellular CarcinomaChina
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingLiver Cancer, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Cervical Cancer, MSI-H Colorectal CancerChina