An Open Label, Single Arm Phase II Study of Camrelizumab in Combination With Cisplatin and Nab-paclitaxel as a Novel Neoadjuvant Pre-Surgical Therapy for Resectable HNSCC
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study is a single arm phase II trial including 53 patients with T2N2-3M0、T3-4N0-3M0（III-IV） head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive neo-adjvuant Camrelizumab combined with cisplatin and Nab-paclitaxel.
This proposed study will evaluate the efficacy and safety of preoperative administration of Camrelizumab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.
详细描述
In this study, eligible subject will be enrolled into study arm to accept study treatment. Objective response rate will be the primary outcome measures.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Severe allergic reaction to any component of PD-1 monoclonal antibodies or other monoclonal antibodies.
- •Active, known or suspected autoimmune disease, including dementia and epilepsy.
- •Has had another known invasive malignancy or unresectable cancer.
- •Coagulation dysfunction: (PT > 16S, APTT > 53s, TT > 21s, FIB < 1.5g / L), bleeding tendency or thrombolysis, anticoagulation treatment.
- •Severe cardiac disease, lung dysfunction, heart function and lung function lower than grade 3 (≤3).
- •Laboratory abnormality within 7 days before enrollment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications before enrollment.
- •Has a known history of Human Immunodeficiency Virus (HIV).
- •Has a known history of Hepatitis B (defined as HBV DNA ≥1000 cps/mL is detected) or known active Hepatitis C virus (defined as: HCV antibody positive) infection.
- •have received anti-tumor herbs within 4 weeks before randomization.
- •Pregnant or nursing women.
研究组 & 干预措施
Experimental
Camrelizumab + Cisplatin + Nab-paclitaxel
Camrelizumab (IV), dose= 200mg , day=1 , cycle length: 21 days. Cisplatin (IV), dose=60mg/m2, day= 1, cycle length: 21 days. Nab-paclitaxel (IV), dose=260mg/m2, day= 1, cycle length: 21 days.
干预措施: Camrelizumab, nab-paclitaxel, cisplatin (Drug)
结局指标
主要结局
ORR
时间窗: 9 weeks
overall response rate
次要结局
- pCR(9 weeks)
- MPR(9 weeks)
- DCR(9 weeks)
- PFS(2 years)
- OS(5 years)
- Adverse events graded by CTCAE v5.0(90 days after the first dose of study treatment)
研究者
Xuekui Liu
Professor
Sun Yat-sen University