A Prospective Single-Arm Study(NCLDR)

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 30, 2025

Primary Completion Date

August 30, 2026

Study Completion Date

August 30, 2027

Conditions
Oral Squamous Cell Carcinoma (OSCC)
Interventions
RADIATION

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.

DRUG

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).

PROCEDURE

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.

DRUG

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."

RADIATION

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."

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER