This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
Age: 18-75 years old.
Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Distant Metastasis: Presence of distant metastasis.
Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
Infections: Active infection requiring systemic therapy.
Single group
Serplulimab
DrugSerplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.
Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)
DrugPaclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.
Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)
DrugPaclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.
Radiotherapy
RadiationRadiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.
Pathological Complete Response (pCR) Rate
The proportion of patients achieving a pathological complete response (pCR) after neoadjuvant treatment and surgical resection. pCR is defined as the absence of any residual invasive cancer in the resected esophagus and all sampled lymph nodes (ypT0N0) based on hematoxylin and eosin staining.
R0 Resection Rate
The proportion of patients achieving an R0 resection, defined as a microscopically margin-negative resection with no residual tumor at the resection margins.
Treatment-Related Toxicity
The incidence and severity of treatment-related adverse events, graded according to CTCAE 5.0. This includes adverse events related to Serplulimab, Paclitaxel, Cisplatin, and radiotherapy, as well as surgical complications.
3-Year Disease-Free Survival (DFS)
The percentage of patients who remain disease-free three years after surgical resection. DFS is defined as the time from R0 resection to the first occurrence of disease recurrence or death from any cause.
Tumor Mutational Burden (TMB)
Tumor mutational burden (TMB) score as measured in tumor tissue samples.
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