This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
Measurable or evaluable disease per RECIST 1.1
Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
Parallel
Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)
DrugPaclitaxel 150-175 mg/m² combined with cisplatin 75 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.
Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)
DrugPaclitaxel 50 mg/m² combined with cisplatin 25 mg/m² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.
Complete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)
Proportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
1-Year Progression-Free Survival (PFS) Rate
Proportion of patients alive and without disease progression at 1 year after randomization
Overall Survival (OS)
Time from randomization to death from any cause
Progression-Free Survival (PFS)
Time from randomization to first documented disease progression or death from any cause, whichever occurs first
Duration of Response (DOR)
Time from first documentation of objective response (CR/PR) to first documented disease progression or death
Objective Response Rate (ORR)
Proportion of patients achieving CR or partial response (PR) per RECIST 1.1
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