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Clinical Trial Summary

In recent years, immunotherapy has become one of the important treatments for malignant tumors. Among them, PD-1 inhibitors have been widely used in clinical practice, and have shown a significant survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, we intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04840355
Study type Observational
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact
Status Recruiting
Phase
Start date February 26, 2021
Completion date October 1, 2024

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