Study to Monitor and Predict Immune Side Effects from Sintilimab Treatment in Adults with Cancer Using Gene Expression Patterns

What this Trial Is About

Researchers are investigating immune-related adverse events irAEs caused by Sintilimab, a PD-1 inhibitor used in treating malignant tumors. This observational study aims to predict and prevent severe irAEs, which can threaten patients lives, by establishing a warning model based on gene expression programming GEP using multi-dimensional data such as genes, metabolites, and immune factors. The study involves patients receiving Sintilimab treatment to better understand irAE risks and improve safety management. Participants receive Sintilimab by intravenous infusion at a recommended dose of 200 mg on day 1, repeated every 21 days for up to 6 months, provided there is no disease progression or unacceptable toxicity. The study uses a prospective cohort design with samples divided into training and verification sets across multiple centers to develop and validate the irAE recognition model. This approach helps identify high-risk patients early and supports prevention strategies during clinical practice. During the 24-month study period, researchers monitor and collect time-series multi-dimensional biological data from participants, including gene expression and immune markers. They assess irAEs severity and frequency, dividing subjects into groups based on irAE degrees. Safety and treatment effects are tracked through clinical evaluations and laboratory tests to identify early signs of adverse immune reactions. The study helps develop predictive tools for managing Sintilimab-induced irAEs and enhances patient safety over the long term.

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