A Phase II Study of SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- rate of pathological complete response
研究概览
简要总结
In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed squamous carcinoma of oral cavity or oropharynx
- •III-IVa based on the eighth edition of AJCC
- •aged 18 to 70
- •ECOG PS 0-1
- •no organ dysfunction
- •Expected survival ≥ 3 months
排除标准
- •diagnosed with other malignant tumors
- •has autoimmune diseases or serious mental illness
- •at high risk of hemorrhage
- •Systemic or local glucocorticoid therapy within 4 weeks
- •Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses
- •Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- •Prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody
- •HIV or HCV
- •HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml
结局指标
主要结局
rate of pathological complete response
时间窗: immediately after the surgery
pathological complete response rate after radical resection
次要结局
- overall survival(3-year)
- rate of adverse events(one month after the postoperative radiotherapy)
- disease free survival(3-year)
- rate of major pathological response(immediately after the surgery)
- objective response rate(two weeks after the chemoimmunotherapy)
研究者
Fang-Yun Xie
professor
Sun Yat-sen University