drugset / Trial / NCT07346807

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

NCT07346807 ↗

Phase 2 Not yet recruiting 69 enrolled Shanghai Zhongshan Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-01
Primary completion
2026-10-31
Completion
2026-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin-Bound Paclitaxel Unknown 260 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous