Minimal residual disease guided radical chemoradiotherapy combined with immunotherapy after neoadjuvant immunochemotherapy followed by adjuvant immunotherapy for esophageal squamous cell cancer (ECMRD-001): a study protocol for a prospective cohort study

• DOI: 10.3389/fimmu.2023.1330928
• Publication Date: 2024-01-11T04:23:22Z
• Authors: Hesong Wang; Xueyuan Zhang; Xiaohan Zhao; Chunyang Song; Wenzhao Deng; Wenbin Shen
• Keywords: Chemoradiotherapy; Minimal Residual Disease

Introduction For locally advanced, inoperable esophageal cancer, concurrent chemoradiotherapy (CCRT) becomes the norm. Combining immunotherapy with radiotherapy has been shown to improve efficacy. Circulating tumor DNA (ctDNA) is a strong predictor of effectiveness and recurrence indicative minimal residual disease (MRD). Patients stage II-III squamous cell carcinoma (ESCC) are enrolled in ECMRD-001 trial evaluate changes MRD status before after CCRT combined adjuvant following neoadjuvant immunochemotherapy. Methods analysis The prospective cohort study. Eligible patients will receive radical immunochemotherapy, followed by for at least one year. Follow-up be up three years. MRD-related blood tissue samples T-cell immunohistobank related collected before, during treatment follow-up grouped into sample collection time points. relationship between different points efficacy primary outcome. Correlation immune microenvironment, dose, secondary outcomes. Examination ctDNA mutations exploratory Discussion ctDNA-based may potential predictive marker ESCC patients. Elevated ctDNA-MRD predict earlier than imaging. guided diagnosis should implemented clinical practice reduce ESCC. Trial registration study registered ClinicalTrials.gov as NCT05952661 (July 19, 2023), https://classic.clinicaltrials.gov/ct2/show/NCT05952661 .