Tongue Squamous Cell CarcinomaPhase 2NCT07346807
Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer
A Phase 2 study testing Lingual Nerve Disruption, Tislelizumab and Albumin-bound Paclitaxel in people with Tongue Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tongue Squamous Cell Carcinoma
- What is being tested?
- Lingual Nerve Disruption, Tislelizumab and Albumin-bound Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.
Who cannot join
- 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.
- Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.
- Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).
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- Active serious clinical infections (>Grade 2 NCI-CTCAE v5.0).
- 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.
- 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
- Pregnant women; breastfeeding women must discontinue breastfeeding to participate.
- History of substance abuse or psychiatric disorders that would interfere with study participation.
- Participation in another clinical trial within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Tong Ji, PhD, 86-13651658767, ji.tong@zs-hospital.sh.cn
About this study
Official title: 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:
Read more
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
- Being tested
- Lingual Nerve Disruption, Tislelizumab, Albumin-bound Paclitaxel, Cisplatin, Peripheral Blood Collection for Immune Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual Nerve DisruptionProcedure or surgery
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.
TislelizumabDrug
Anti-PD-1 monoclonal antibody administered intravenously at 200 mg on day 1 of each 3-week cycle.
Albumin-bound PaclitaxelDrug
Chemotherapy agent administered intravenously at 260 mg/m² on day 2 of each 3-week cycle.
CisplatinProcedure or surgery
Chemotherapy agent administered intravenously at 75 mg/m² on day 2-3 of each 3-week cycle.
Peripheral Blood Collection for Immune MonitoringProcedure or surgery
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.
Pain and Quality of Life AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy | Experimental | Not described Receives: Procedure: Lingual Nerve Disruption; Drug: Tislelizumab; Drug: Albumin-bound Paclitaxel; Procedure: Cisplatin; Procedure: Peripheral Blood Collection for Immune Monitoring; Other: Pain and Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR) Rate
Measured: 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 outcomes (1)
Preoperative Pain Score Improvement Rate
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346807
- Sponsor's protocol ID
- B2025-792R
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Study of Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer
- ClinicalTrials.gov ID
- NCT07346807
- Acronym / sponsor ID
- B2025-792R
- Conditions
- Tongue Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy | Experimental | Procedure: Lingual Nerve Disruption, Drug: Tislelizumab, Drug: Albumin-bound Paclitaxel, Procedure: Cisplatin, Procedure: Peripheral Blood Collection for Immune Monitoring, Other: Pain and Quality of Life Assessment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.
Key exclusion criteria (13 listed)
- 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.
- Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lingual Nerve DisruptionSurgical 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. | Procedure or surgery | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
| TislelizumabAnti-PD-1 monoclonal antibody administered intravenously at 200 mg on day 1 of each 3-week cycle. | Drug | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
| Albumin-bound PaclitaxelChemotherapy agent administered intravenously at 260 mg/m² on day 2 of each 3-week cycle. | Drug | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
| CisplatinChemotherapy agent administered intravenously at 75 mg/m² on day 2-3 of each 3-week cycle. | Procedure or surgery | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
| Peripheral Blood Collection for Immune MonitoringPeripheral 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. | Procedure or surgery | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
| Pain and Quality of Life AssessmentMcGill Pain Questionnaire and quality-of-life surveys administered before each cycle of neoadjuvant therapy to assess treatment impact on pain relief and functional outcomes. | Other | Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lingual Nerve Disruption, Tislelizumab and Albumin-bound Paclitaxel in people with Tongue Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tong Ji, PhD (86-13651658767, ji.tong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.