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A Prospective Single-Arm Study(NCLDR)
Sponsor: Qilu Hospital of Shandong University
Summary
To investigate the safety and efficacy of low-dose radiotherapy combined with chemotherapy and immunotherapy as neoadjuvant therapy for locally advanced oral squamous cell carcinoma (OSCC), and to explore whether low-dose radiotherapy can induce cross-presentation of tumor-specific antigens, enhance lymphocyte infiltration into the tumor microenvironment, and thereby amplify tumor-specific immune responses, ultimately improving the therapeutic outcomes of neoadjuvant chemoimmunotherapy.
Official title: Phase II Trial of Neoadjuvant Chemoimmunotherapy With Low-Dose Radiotherapy in Locally Advanced Oral Squamous Cell Carcinoma: A Prospective Single-Arm Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-08-30
Completion Date
2027-08-30
Last Updated
2025-06-19
Healthy Volunteers
No
Conditions
Interventions
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.