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

NCT07346807 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-01-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346807 on ClinicalTrials.gov