NCT07346807

Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer

A Phase II Single-Arm Study of Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tongue Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Lingual Nerve Disruption	Surgical 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.
DRUG	Tislelizumab	Anti-PD-1 monoclonal antibody administered intravenously at 200 mg on day 1 of each 3-week cycle.
DRUG	Albumin-bound Paclitaxel	Chemotherapy agent administered intravenously at 260 mg/m² on day 2 of each 3-week cycle.
PROCEDURE	Cisplatin	Chemotherapy agent administered intravenously at 75 mg/m² on day 2-3 of each 3-week cycle.
PROCEDURE	Peripheral Blood Collection for Immune Monitoring	Peripheral 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.
OTHER	Pain and Quality of Life Assessment	McGill Pain Questionnaire and quality-of-life surveys administered before each cycle of neoadjuvant therapy to assess treatment impact on pain relief and functional outcomes.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China