[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619606":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":46,"locations":56,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy","EXPERIMENTAL",null,[13,14,15,16,17,18],"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",[20,25,30,34,38,42],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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.",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Tislelizumab","Anti-PD-1 monoclonal antibody administered intravenously at 200 mg on day 1 of each 3-week cycle.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Albumin-bound Paclitaxel","Chemotherapy agent administered intravenously at 260 mg\u002Fm² on day 2 of each 3-week cycle.",[9],{"type":21,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Cisplatin","Chemotherapy agent administered intravenously at 75 mg\u002Fm² on day 2-3 of each 3-week cycle.",[9],{"type":21,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"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.",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"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.",[9],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Tong Ji, PhD","CONTACT","86-13651658767","ji.tong@zs-hospital.sh.cn",{"name":53,"role":49,"phone":54,"phoneExt":11,"email":55},"Yu Zhang, PhD","86-13818927554","zhang.yu4@zs-hospital.sh.cn",[57],{"facility":58,"status":11,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Zhongshan Hospital Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":65,"coordinates":66},"Point",[67,68],121.45806,31.22222,{"lat":68,"lon":67},[71],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619606","phase-2-lingual-nerve-disruption-to-augment-neoadjuvant-chemoimmunotherapy-in-locally-advanced-tongue-cancer-100619606",false,"NCT07346807","Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer","A Phase II Single-Arm Study of Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer","Inclusion Criteria:\n\n1. Age 18-75 years, male or female.\n2. Histologically or cytologically confirmed primary tongue squamous cell carcinoma (cT3 or cT4).\n3. Patients scheduled to receive 2 cycles of preoperative neoadjuvant chemoimmunotherapy with tirelizumab, cisplatin, and albumin-bound paclitaxel.\n4. Patients planned to undergo surgical resection of tongue cancer following neoadjuvant therapy.\n5. Voluntary participation with signed informed consent, good compliance, and willingness to follow study procedures.\n\nExclusion Criteria:\n\n1. Known distant metastases of the tumor.\n2. History of tongue squamous cell carcinoma or other malignant tumors of the tongue within the past 5 years.\n3. Active infection requiring systemic therapy; non-infectious pneumonia or interstitial lung disease requiring steroid therapy, or current pneumonia\u002Finterstitial lung disease; known hepatitis B infection (HBsAg positive) or active hepatitis C infection (detectable HCV RNA); known HIV infection.\n4. Previous allogeneic tissue or organ transplantation.\n5. Unresolved ≥Grade 2 (CTCAE v5.0) toxicities from prior anticancer treatments, except alopecia.\n6. Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, NYHA class ≥II heart disease within 3 months prior to enrollment).\n7. Active serious clinical infections (\\>Grade 2 NCI-CTCAE v5.0).\n8. Uncontrolled hypertension (treated systolic BP \\>150 mmHg and\u002For 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.\n9. Laboratory abnormalities:\n\n   Hematology: WBC \\\u003C3,000\u002Fmm³, Hb \\\u003C8 g\u002FdL, platelets \\\u003C80,000\u002Fmm³ Liver function: ALT\u002FAST \\>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\u002FL) Proteinuria: urine protein ≥++ and 24-hour urine protein \\>1.0 g\n10. Pregnant women; breastfeeding women must discontinue breastfeeding to participate.\n11. History of substance abuse or psychiatric disorders that would interfere with study participation.\n12. Participation in another clinical trial within 30 days prior to enrollment.","ALL","18 Years","75 Years",{"count":85,"type":86},69,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","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.\n\nThe 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\u002FT4) tongue cancer. The main questions it aims to answer are:\n\nCan lingual nerve disruption combined with neoadjuvant chemoimmunotherapy improve tumor response prior to surgery?\n\nIs this combined treatment approach safe and feasible for patients with locally advanced tongue cancer?\n\nThis is a single-arm, phase II clinical trial.\n\nParticipants will:\n\nUndergo tumor biopsy with simultaneous surgical disruption of the affected-side lingual nerve.\n\nReceive neoadjuvant chemoimmunotherapy consisting of tislelizumab, cisplatin, and nab-paclitaxel for two treatment cycles.\n\nUndergo definitive surgical resection of the primary tumor and neck dissection.\n\nAttend scheduled follow-up visits for safety assessments, imaging evaluations, and collection of blood samples for immune monitoring.",[92],"Tongue Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-01-08",{"date":96,"type":97},"2026-01-16","ACTUAL",{"date":99,"type":86},"2026-01-01",{"date":101,"type":86},"2026-10-31",{"name":5,"class":6},1]