Study to Accurately Assess Pseudoprogression in Rectal Cancer Immunotherapy Using MRI and Blood Tests

What this Trial Is About

Researchers are investigating how to accurately assess pseudoprogression a treatment-related effect that can look like tumor growth following immunotherapy in patients with rectal cancer. This observational study uses multiple MRI scans taken at different times and parameters, alongside blood biomarkers and clinical indicators, to evaluate changes after immunotherapy treatment. The goal is to improve the ability to distinguish true tumor progression from pseudoprogression in this patient group. Participants undergo multiparametric MRI scans before starting immunotherapy, and again at 6 and 12 weeks after treatment. Blood tests measuring markers such as IL-8, NLR, LDH, and S100, as well as clinical indicators like KPS score, CEA level, and T-stage, are collected at the same time points. Follow-up imaging and pathological assessments are used to confirm disease status. The study involves a single observational group without experimental interventions. Throughout the study, researchers collect imaging, blood, and clinical data to build predictive models for pseudoprogression. They will analyze accuracy, sensitivity, specificity, and predictive values of these models from baseline to preoperative MRI. Long-term outcomes including disease-free and overall survival will be monitored for up to 60 months. Participants will be followed to evaluate immunotherapy response and disease progression using standardized criteria and pathology when needed.

A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI