A Prospective Randomized Controlled Trial Comparing Low-Dose Radiotherapy Combined With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone as Neoadjuvant Therapy in Patients With Operable Head and Neck Squamous Cell Carcinoma.
This study aimed to compare the efficacy of neoadjuvant low-dose radiotherapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone in patients with resectable head and neck squamous cell carcinoma.
• Age 18 years or above. 2.Patients with pathologically confirmed HNSCC (except for nasopharyngeal carcinoma) and meet the following condition:
⁃ Were newly diagnosed and without distant metastasis; were deemed surgically resectable, evaluated by a head and neck surgeon;
⁃ Were willing to undergo surgery.
⁃ Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
⁃ Adequate organ and bone marrow function:
‣ Absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 80 g/L, platelets ≥ 80 × 10\^9/L;
∙ ALT, AST and ALP \< 2.5× upper limit of normal (ULN), total bilirubin ≤ 2×ULN; albumin≥ 2.8 g/dL；
• Creatinine clearance ≥ 60 ml/min； ④INR≤ 1.5, APTT≤ 1.5×ULN; ⑤Written informed consent.