35
Participants
Start Date
August 30, 2025
Primary Completion Date
August 30, 2026
Study Completion Date
August 30, 2027
Low dose radiotherapy regimen
On the first and second day of chemotherapy and immunotherapy, low-dose radiotherapy of 1 Gy/1f was administered to the primary tumor lesion and metastatic lymph nodes, respectively, for a total of 4 Gy/4f.
New adjuvant immunotherapy regimen
Terriptylimab: fixed dose 240 mg, q30000, intravenous infusion, each infusion lasting 30 minutes (not less than 20 minutes, not more than 60 minutes); Chemotherapy regimen: Albumin bound paclitaxel: 175-260 mg/m2, d1, q3w; Platinum class: Cisplatin: 75mg/m2, d1-3, q3w; Carboplatin: AUC=5, d1, q3w (for patients with cisplatin allergy, intolerance, hearing impairment, creatinine clearance rate\<50ml/min, or grade 1 neuropathy that are not suitable for cisplatin use).
Surgical treatment
Surgery begins around 4 weeks after the first day of the second cycle of neoadjuvant therapy. The surgical plan is developed and evaluated by oral surgeons with years of clinical surgical experience. The determination of surgical margins is mainly based on baseline standards before neoadjuvant therapy for tumors, and can be appropriately reduced by oral surgeons depending on the situation.
Postoperative adjuvant therapy plan
"* Patients with postoperative pathological progression of pCR were given maintenance treatment with Triprolizumab Q3W for 1 year.~ * Patients with postoperative pathology not reaching pCR should receive adjuvant radiotherapy (60-66Gy/30-33f) ③ Patients with high-risk recurrence factors in postoperative pathology (positive tumor margin or insufficient safe margin, presence of lymph node extracellular invasion) are given adjuvant radiotherapy and chemotherapy."
Radical radiotherapy plan
"① Radical radiotherapy for the primary lesion and cervical lymphatic drainage area.~② Synchronous cisplatin during radiotherapy: 75mg/m2, d1-3, q3w."
Qilu Hospital of Shandong University
OTHER