A Multicenter, Multiomics, Non-interventional, Real-world Study of the Efficacy and Safety of Immune Checkpoint Inhibitors as First-line Therapy for Advanced Malignancies

What this Trial Is About

Researchers are conducting a real-world, observational study to evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) as the first-line treatment for advanced malignant tumors. The study includes patients with stage IV solid tumors such as non-small-cell lung carcinoma, stomach, breast, and urinary system cancers. The goal is to build a database combining immunohistochemistry, gene detection, imaging data, and survival outcomes to develop predictive models for immunotherapy biomarkers and treatment responses. The study collects various data points including immunohistochemistry results, gene testing, imaging, overall survival, progression-free survival, and objective response rate. It also monitors immune-related adverse events over time. This observational study does not involve experimental treatments but instead observes patients receiving ICIs as part of their standard care. The study spans at least two years for some outcome measures to assess long-term effects and safety. Participants will undergo regular assessments including survival evaluations and monitoring for treatment-related side effects. Data on progression-free survival will be collected at six months, with overall survival and immune-related adverse events followed for up to two years. The study aims to validate the predictive value of biomarker systems for immunotherapy and improve understanding of treatment effects in advanced cancer patients. Total participation duration will vary depending on individual treatment and follow-up schedules.

A Real-world Study of the Efficacy and Safety of ICIs as First-line Therapy for Advanced Malignancies