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);
Sun Yat-sen University
Lead sponsor