The goal of this clinical trial is to evaluate the feasibility and preliminary efficacy of lingual nerve disruption combined with neoadjuvant chemoimmunotherapy in patients with locally advanced tongue squamous cell carcinoma.
The study aims to learn whether surgical disruption of the lingual nerve can enhance the effectiveness of neoadjuvant chemoimmunotherapy before definitive surgery in adults with locally advanced (cT3/T4) tongue cancer. The main questions it aims to answer are:
Can lingual nerve disruption combined with neoadjuvant chemoimmunotherapy improve tumor response prior to surgery?
Is this combined treatment approach safe and feasible for patients with locally advanced tongue cancer?
This is a single-arm, phase II clinical trial.
Participants will:
Undergo tumor biopsy with simultaneous surgical disruption of the affected-side lingual nerve.
Receive neoadjuvant chemoimmunotherapy consisting of tislelizumab, cisplatin, and nab-paclitaxel for two treatment cycles.
Undergo definitive surgical resection of the primary tumor and neck dissection.
Attend scheduled follow-up visits for safety assessments, imaging evaluations, and collection of blood samples for immune monitoring.
Age 18-75 years, male or female.
Histologically or cytologically confirmed primary tongue squamous cell carcinoma (cT3 or cT4).
Patients scheduled to receive 2 cycles of preoperative neoadjuvant chemoimmunotherapy with tirelizumab, cisplatin, and albumin-bound paclitaxel.
Patients planned to undergo surgical resection of tongue cancer following neoadjuvant therapy.
Known distant metastases of the tumor.
History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.
Active infection requiring systemic therapy; non-infectious pneumonia or interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease; known hepatitis B infection (HBsAg positive) or active hepatitis C infection (detectable HCV RNA); known HIV infection.
Previous allogeneic tissue or organ transplantation.
Single group
Lingual Nerve Disruption
Procedure/SurgerySurgical transection of 1 cm of the lingual nerve via intraoral approach under local anesthesia at the time of biopsy. This procedure induces ipsilateral tongue tip numbness to enhance subsequent chemoimmunotherapy efficacy.
Tislelizumab
DrugAnti-PD-1 monoclonal antibody administered intravenously at 200 mg on day 1 of each 3-week cycle.
Albumin-bound Paclitaxel
DrugChemotherapy agent administered intravenously at 260 mg/m² on day 2 of each 3-week cycle.
Cisplatin
Procedure/SurgeryChemotherapy agent administered intravenously at 75 mg/m² on day 2-3 of each 3-week cycle.
Peripheral Blood Collection for Immune Monitoring
Procedure/SurgeryPeripheral blood (10 mL) collected in the morning under fasting conditions at baseline, before each cycle of neoadjuvant therapy, and during follow-up visits. Plasma and peripheral blood mononuclear cells are prepared within 2 hours and stored at -80°C for immune cell dynamic analysis.
Pain and Quality of Life Assessment
Other interventionMcGill Pain Questionnaire and quality-of-life surveys administered before each cycle of neoadjuvant therapy to assess treatment impact on pain relief and functional outcomes.
Major Pathologic Response (MPR) Rate
Preoperative Pain Score Improvement Rate
Dynamic Changes of Immune Cells
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This trial is not recruiting at the moment. You can still explore other options:
