Tumor Draining Lymph Nodes Sparing Radiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial
The goal of this clinical trial is to learn if tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.
• Written informed consent
• Aged 18 years or above
• Histologically confirmed esophageal squamous cell carcinoma
• Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
⁃ 7\. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN