Neoadjuvant Tislelizumab (BGB-A317, Anti-PD-1 Antibody) Plus Nab-Paclitaxel and Carboplatin for Resectable Locally-advanced Head and Neck Squamous Cell Carcinoma : A Single-arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (PCR)
研究概览
简要总结
For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily participate in the project and sign the informed consent.
- •Be 18 years of age on day of signing informed consent.
- •The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-
- •According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVA tumors confirmed by pathology as head and neck squamous cell carcinoma.
- •Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis.
- •Demonstrate adequate organ function.
排除标准
- •The patient has abnormal blood indicators, abnormal liver and kidney function.
- •The patient has received prior systemic anti-cancer therapy for head and neck squamous cell carcinoma including investigational agents within 3 months of first dose of study treatment.
- •The patient has previously suffered from other tumors , or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy within the past 5 years.
- •The entire clinical research process cannot be completed due to personal, social and economic reasons.
- •Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs .
研究组 & 干预措施
Neoadjuvant therapy of tislelizumab with chemotherapy
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
干预措施: Tislelizumab (Drug)
Neoadjuvant therapy of tislelizumab with chemotherapy
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
干预措施: Nab-paclitaxel (Drug)
Neoadjuvant therapy of tislelizumab with chemotherapy
Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles
干预措施: Carboplatin (Drug)
结局指标
主要结局
Pathological Complete Response (PCR)
时间窗: From neoadjuvant therapy to surgical resection, up to 6 weeks
次要结局
- 3-year overall survival（OS）rate(3-years after surgery)
- Major Pathological Response (MPR)(From neoadjuvant therapy to surgical resection, up to 6 weeks)
- 3-year Disease-free survival (DFS) rate(3-years after surgery)
研究者
Xiang Lu
Professor
Tongji Hospital