Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer

What this Trial Is About

Researchers are investigating whether changes in circulating tumor DNA (ctDNA) can help predict early response to immune checkpoint inhibitors (ICIs) in patients with advanced-stage cancers, including lung, colorectal, breast, liver, and gastric cancers. The study also examines conventional tumor markers such as PD-L1, tumor mutational burden (TMB), and microsatellite instability (MSI) to evaluate their combined value in forecasting response to ICI treatment. This observational study enrolls patients aged 18 and older who have stage IV cancer and are starting ICI treatment for the first or second time; concurrent chemotherapy is allowed. Blood samples for ctDNA analysis are taken before treatment and every 3 months during ICI therapy for up to 12 months. Tumor tissue samples are analyzed using advanced sequencing techniques to examine gene mutations, TMB, and MSI. The study collects detailed genetic data to track tumor mutations and assess their impact. Participants will have blood draws, tumor sample analyses, and imaging scans (CT, MRI, or PET-CT) during regular clinic visits over a 2-year follow-up period. Researchers will record medical history, treatment adherence, and other health data. The main outcomes include correlations between ctDNA changes and clinical response to ICI therapy, evaluation of prognostic value of ctDNA clearance, and comparison of PD-L1, TMB, and MSI as predictors of treatment response. The study aims to improve understanding of how these markers relate to treatment effectiveness and patient outcomes.

Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.