This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.
Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma;
Evaluated as unresectable locally advanced esophageal squamous cell carcinoma by endoscopic ultrasound, imaging studies including esophagography, CT of the neck, chest, and upper abdomen, MRI of the neck and chest, whole-body bone scan, or PET/CT, with staging in the range of II-IVB (stage IVB limited to celiac lymph node or supraclavicular lymph node metastasis);
Male or female aged 18 to 80 years;
Eligible for oral drug therapy;
Participation in another clinical trial, unless it is an observational (non-interventional) study;
Use of immunosuppressive drugs within 28 days prior to the first infusion of Toripalimab, excluding physiological doses of intranasal inhaled corticosteroids, prednisone ≤10 mg/day, or equivalent systemic corticosteroids;
Prior use of any anti-PD-1 or anti-PD-L1 antibody;
Major surgery within 4 weeks prior to entering the study (excluding vascular access procedures);
Parallel
Induction chemoimmunotherapy
DrugAll patients will receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.
Hypofractionated Radiation Therapy
RadiationAll patients will receive hypofractionated radiotherapy once daily, five days per week, followed by a boost. Three weeks after the completion of the first phase of hypofractionated radiotherapy, tumor response and cardiopulmonary function will be evaluated. For patients who achieve a partial response, have no deep esophageal ulcers on endoscopy, and have cardiopulmonary function tolerating the radiotherapy boost, a second phase of radiotherapy will be planned using a new CT simulation and radiotherapy design. First Phase of Radiotherapy: Total dose of 2500 cGy in 5 fractions (500 cGy per fraction) Second Phase of Radiotherapy: Total dose of 2500 cGy in 10 fractions (250 cGy per fraction) The interval between the two phases of radiotherapy will be 28 days.
Conventional Fractionated Radiation Therapy
RadiationPatients will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.
Concurrent Chemotherapy
DrugCapecitabine oral administration, 1000 mg/m², twice daily
Progression-free survival rate
The proportion of patients who remain free from disease progression during a defined period after treatment initiation.
Overall survival rate
The proportion of patients who are still alive after a specified period of time, regardless of disease progression or relapse.
Clinical response rate
The percentage of patients who had partial remission or complete remission after therapy
Rate of grade 3 or higher toxicities
The percentage of patients who develop grade 3 or higher toxicities. The toxicities are evaluated based on Common Terminology Criteria for Adverse Events version 5.0. The values range from 1 to 5. A higher score means a worse outcome.
Distant metastasis-free survival rate
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