This prospective observational study (PKU-ESCC-Monitor) aims to characterize the dynamic evolution of esophageal squamous cell carcinoma (ESCC) using integrated multi-omics, including tissue genomics, ctDNA, imaging features, immune profiling and microbiome. Two cohorts will be followed: a peri-operative cohort after standard neoadjuvant therapy and surgery, and an advanced cohort receiving first-line immunotherapy. Clinical outcomes (DFS/PFS/OS) and biomarker dynamics will be analyzed to improve risk stratification and response prediction.
The study integrates clinical data with multi-omics (tumor tissue, surgical specimens, archived FFPE slides where applicable, serial blood for ctDNA and cytokines such as IL-6/IL-8, and exploratory immune/microbiome assessments). Patients are followed monthly or per routine visits up to 36-60 months. Analyses include RECIST 1.1-based responses (ORR, DCR, TTR, DOR), survival endpoints, and biomarker-clinical modeling to delineate ESCC evolutionary patterns and treatment response.
Study Type
OBSERVATIONAL
Enrollment
255
Disease-Free Survival (DFS)
peri-operative cohort; time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Time frame: up to 60 months
Progression-Free Survival (PFS)
advanced cohort;time from start of first-line therapy to first documented disease progression per RECIST 1.1 or death.
Time frame: up to 36 months
Overall Survival (OS)
time from study registration to death from any cause.
Time frame: up to 60 months
Time to Response (TTR)
time from study registration to first ESCC recurrence or death from any cause; patients alive without recurrence are censored at last contact.
Time frame: up to 60 months
Objective Response Rate (ORR)
up to 24 months
Time frame: best overall response up to 24 months; proportion with CR/PR by RECIST 1.1.
Disease Control Rate (DCR)
up to 24 months
Time frame: up to 24 months; proportion with CR/PR/SD by RECIST 1.1.
Biomarker Analyses
exploratory associations for PD-L1, HER2, EGFR, ctDNA dynamics, IL-6/IL-8 and other immune/microbiome markers with outcomes.
Time frame: baseline to 36-60 months
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