A Phase II Single-Arm Study of Lingual Nerve Disruption to Augment Neoadjuvant Chemoimmunotherapy in Locally Advanced Tongue Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Major Pathologic Response (MPR) Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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.
研究组 & 干预措施
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Lingual Nerve Disruption (Procedure)
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Tislelizumab (Drug)
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Albumin-bound Paclitaxel (Drug)
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Cisplatin (Procedure)
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Peripheral Blood Collection for Immune Monitoring (Procedure)
Lingual Nerve Disruption + Neoadjuvant Chemoimmunotherapy
干预措施: Pain and Quality of Life Assessment (Other)
结局指标
主要结局
Major Pathologic Response (MPR) Rate
时间窗: 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)
次要结局
- Preoperative Pain Score Improvement Rate(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))