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

January 8, 2026 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years, male or female.
  2. Histologically or cytologically confirmed primary tongue squamous cell carcinoma (cT3 or cT4).
  3. Patients scheduled to receive 2 cycles of preoperative neoadjuvant chemoimmunotherapy with tirelizumab, cisplatin, and albumin-bound paclitaxel.
  4. Patients planned to undergo surgical resection of tongue cancer following neoadjuvant therapy.
  5. Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.

Exclusion Criteria:

  1. Known distant metastases of the tumor.
  2. History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.
  3. 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.
  4. Previous allogeneic tissue or organ transplantation.
  5. Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.
  6. Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).
  7. Active serious clinical infections (>Grade 2 NCI-CTCAE v5.0).
  8. Uncontrolled hypertension (treated systolic BP >150 mmHg and/or diastolic BP >90 mmHg) or clinically significant cardiovascular disease, including recent cerebrovascular accident or myocardial infarction (≤6 months), unstable angina, NYHA class ≥II congestive heart failure, or severe arrhythmia not controlled by medication that could affect study treatment.

  9. Laboratory abnormalities:

    Hematology: WBC <3,000/mm³, Hb <8 g/dL, platelets <80,000/mm³ Liver function: ALT/AST >3× upper limit of normal, bilirubin >1.5× ULN Renal function: serum creatinine >1.5× ULN, renal failure requiring dialysis Diabetes: poorly controlled (FBG >10 mmol/L) Proteinuria: urine protein ≥++ and 24-hour urine protein >1.0 g

  10. Pregnant women; breastfeeding women must discontinue breastfeeding to participate.
  11. History of substance abuse or psychiatric disorders that would interfere with study participation.
  12. Participation in another clinical trial within 30 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Pathologic Response (MPR) Rate
Time Frame: From baseline (day1, before biopsy and lingual nerve disruption) to surgery (3 weeks after completion of 2 cycles of neoadjuvant therapy, which starts 1 week after the biopsy. Each cycle of neoadjuvant therapy is 21 days/3 weeks)
From baseline (day1, before biopsy and lingual nerve disruption) to surgery (3 weeks after completion of 2 cycles of neoadjuvant therapy, which starts 1 week after the biopsy. Each cycle of neoadjuvant therapy is 21 days/3 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Preoperative Pain Score Improvement Rate
Time Frame: From baseline (day1, before biopsy and lingual nerve disruption) to surgery (3 weeks after completion of 2 cycles of neoadjuvant therapy, which starts 1 week after the biopsy. Each cycle of neoadjuvant therapy is 21 days/3 weeks)
From baseline (day1, before biopsy and lingual nerve disruption) to surgery (3 weeks after completion of 2 cycles of neoadjuvant therapy, which starts 1 week after the biopsy. Each cycle of neoadjuvant therapy is 21 days/3 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
Dynamic Changes of Immune Cells
Time Frame: At 5 specific time points during the study: Baseline (day1) Before second cycle of neoadjuvant therapy (day28 / 4 weeks) After second cycle of neoadjuvant therapy before surgery (day49 / 7weeks) 4 weeks after surgery(day77) 3 months after surgery(day139)
At 5 specific time points during the study: Baseline (day1) Before second cycle of neoadjuvant therapy (day28 / 4 weeks) After second cycle of neoadjuvant therapy before surgery (day49 / 7weeks) 4 weeks after surgery(day77) 3 months after surgery(day139)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2025-792R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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