Multicenter Phase III Randomized Controlled Clinical Trial of Proton Radiotherapy versus Photon Radiotherapy with Concurrent Chemotherapy Followed by Immunotherapy Consolidation for Locally Advanced Esophageal Squamous Cell Carcinoma

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: treatment group:Proton Radiotherapy with Concurrent Chemotherapy Followed by Immunotherapy Consolidation;Control group:Photon Radiotherapy with Concurrent Chemotherapy Followed by Immunotherapy Consolidation; CONDITION: Esophageal Squamous Cell Carcinoma PRIMARY OUTCOME: Overall survival (OS); SECONDARY OUTCOME: Incidence of grade =2 pneumonia;TRAEs;Various quality‐of‐life scales;Overall survival time without cancer;Cancer‐specific overall survival time;Progression‐free survival; INCLUSION CRITERIA: 1. Sign the informed consent; 2. 18‐80 years old, male and female; 3. Esophageal squamous cell carcinoma confirmed by cytology or histology; 4. Stage II‐ (isolated supraclavicular lymph node metastasis) IVB by imaging evaluation; 5. Patients were evaluated as unresectable by MDT, or patients refused surgery, or patients were evaluated as unable to tolerate surgery due to medical reasons; 6. ECOG: 0‐1; 7. Expected survival time >= 12 weeks; 8. Adequate organ function: (1) Hematologic function: White blood cell count (WBC) >= 3.5×10^9/L, absolute neutrophil count (ANC) >= 1.8×10^9/L, platelet count >= 75×10^9/L, hemoglobin >= 10 g/dL; (2) Adequate liver function: ALT and AST <= 1.5× upper limit of normal (ULN), bilirubin <= 1.5× ULN; (3) Adequate kidney function: In adults, endogenous creatinine clearance >= 80 mL/min or serum creatinine (SCR) <= ULN, BUN <= ULN; and urine protein < 2. For patients with baseline urine protein >= 2, a 24‐
Epistemonikos ID: 0f7422a321ba8234c0dc7ef2a2897ac54bd698c5
First added on: Oct 08, 2026