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Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients

NCT04840355 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-12-27

No results posted yet for this study

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, the investigators 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.

Conditions

  • Immune Related Adverse Events
  • PD-1

Interventions

DRUG

Sintilimab Injection

The recommended dose for intravenous infusion is 200 mg on day 1.Courses repeat every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Guohui Li

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2025-11-14
Completion
2025-11-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840355 on ClinicalTrials.gov