Nerve cut may supercharge tongue cancer treatment
NCT ID NCT07346807
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether surgically cutting the lingual nerve (which controls tongue sensation) can make chemoimmunotherapy work better for people with advanced tongue cancer. 69 adults with stage T3/T4 tongue cancer will receive the nerve cut along with two cycles of tislelizumab, cisplatin, and nab-paclitaxel before standard surgery. The main goal is to see if this combination improves tumor response before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lingual nerve disruption (surgical nerve cut), tislelizumab (immunotherapy), albumin-bound paclitaxel and cisplatin (chemotherapy)
- What this could lead to
- If it works, this could point toward a way to make standard chemoimmunotherapy more effective for advanced tongue cancer before surgery.
- What could go wrong
- This is a small, early-phase trial with only 69 people and no comparison group. The nerve-cutting procedure is experimental and may cause permanent numbness or other side effects without improving outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
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Other studies related to the condition(s) this trial covers.
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