This prospective observational study aims to characterize dynamic changes in the tumor microenvironment of patients with esophageal squamous cell carcinoma receiving standard neoadjuvant chemotherapy combined with immunotherapy followed by surgical resection. Paired tumor tissue samples will be collected before treatment and at surgery, and peripheral blood samples may also be collected when feasible. Single-cell RNA sequencing and spatial transcriptomics will be used to evaluate changes in cellular composition, transcriptional states, and spatial organization within the tumor microenvironment and to explore their associations with pathological response.
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This study will enroll adults with pathologically confirmed, potentially resectable esophageal squamous cell carcinoma who are scheduled to receive standard neoadjuvant chemotherapy combined with immunotherapy followed by surgery. Participants will be recruited from routine clinical practice at a single center. Tumor tissue will be collected before treatment and again at the time of surgical resection, and peripheral blood samples may also be collected when feasible for translational analyses of tumor microenvironment changes associated with pathological response and clinical outcomes.
Cohort
Prospective
Biological: Tumor Tissue and Blood Sample Collection
Other interventionTumor tissue samples will be collected at baseline before treatment and again at the time of surgical resection. Peripheral blood samples may also be collected when feasible. Collected biospecimens will be used for single-cell RNA sequencing, spatial transcriptomics, and related molecular analyses to evaluate dynamic changes in the tumor microenvironment associated with treatment response.
Major Pathological Response Rate
Major pathological response rate, defined as the proportion of participants with 10 percent or less residual viable tumor in the resected primary tumor specimen after neoadjuvant chemo-immunotherapy.
Pathological Complete Response Rate
Pathological complete response rate, defined as the proportion of participants with no residual viable tumor identified in the resected primary tumor specimen and sampled regional lymph nodes after neoadjuvant chemo-immunotherapy.
Event-Free Survival
Event-free survival, defined as the time from treatment initiation to disease progression preventing surgery, postoperative recurrence, or death from any cause.
Change in Proportion of CD8-positive T Cells in Tumor Tissue
Change in the proportion of CD8-positive T cells among total cells in paired tumor tissue samples collected before treatment and at the time of surgical resection, assessed by single-cell RNA sequencing.
Change in T-cell Exhaustion Signature Score
Change in the predefined T-cell exhaustion gene signature score in paired tumor tissue samples collected before treatment and at the time of surgical resection, assessed by single-cell RNA sequencing.
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