Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.
This prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.
The study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.
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Single group
Neoadjuvant Chemoimmunotherapy (Tislelizumab Plus Paclitaxel and Cisplatin)
DrugParticipants will receive neoadjuvant chemoimmunotherapy before surgery. The regimen includes: Tislelizumab (PD-1 inhibitor): 200 mg administered intravenously once every 3 weeks for 2 cycles. Paclitaxel: 135 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. Cisplatin: 60 mg/m² administered intravenously on Day 1 of each 3-week cycle for 2 cycles. After completion of neoadjuvant chemoimmunotherapy, tumor response will be assessed. Treatment decisions will be guided by early response evaluation and multidisciplinary surgical assessment.
Sequential Chemoradiotherapy
RadiationParticipants with inadequate response after neoadjuvant chemoimmunotherapy but remaining eligible for curative surgery will receive sequential chemoradiotherapy followed by surgery. Concurrent chemoradiotherapy consists of: Radiotherapy: 1.8 Gy per fraction, 5 fractions per week, for 5 weeks, with a total dose of 41.4 Gy in 23 fractions. Chemotherapy: weekly concurrent chemotherapy with paclitaxel and platinum-based chemotherapy during radiotherapy. The treatment aims to improve local tumor control before radical surgical resection.
Safety and Tolerability Equivalent Major Pathological Response Rate (ITT-MPR)
R0 Resection Rate
The proportion of participants achieving microscopically complete tumor resection (R0 resection) after surgery.
Surgical Completion Rate
The proportion of participants who successfully complete planned surgical resection after neoadjuvant treatment.
Pathological Complete Response (pCR) Rate
The proportion of participants achieving pathological complete response (ypT0N0) based on surgical pathology evaluation after neoadjuvant treatment.
Tumor Regression Grade (TRG)
Tumor regression grade assessed by pathological examination after surgical resection.
Event-Free Survival (EFS)
Event-free survival is defined as the time from initiation of study treatment to disease progression, recurrence, death, or other predefined events.
Overall Survival (OS)
Overall survival is defined as the time from initiation of study treatment to death from any cause.
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from R0 surgical resection to disease recurrence or death from any cause.
Quality of Life Assessed by EORTC QLQ-C30
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
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