Efficacy and Safety of Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-001)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Major pathologic response
研究概览
简要总结
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.
详细描述
The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.
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
- •Histologically confirmed esophageal squamous cell carcinoma;
- •Potentially resectable cT3N1M0，cT1-3N2M0(stage III)(AJCC 8 TNM classification);
- •Have a performance status of 0 or 1 on the ECOG Performance Scale;
- •Age 18-70 years old, both men and women;
- •Be willing and able to provide written informed consent/assent for the trial;
- •Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- •Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day
- •Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
排除标准
- •Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
- •Ineligibility or contraindication for esophagectomy;
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
- •Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
研究组 & 干预措施
Pembrolizumab+ Paclitaxel+Cisplatin
Pembrolizumab 200mg D1; Paclitaxel 135mg/m2 D2; Cisplatin 20mg/m2 D2-D4; repeated every 3 weeks
干预措施: Pembrolizumab Injection [Keytruda] (Drug)
结局指标
主要结局
Major pathologic response
时间窗: 3 months
Viable tumor comprised ≤ 10% of resected tumor specimens
次要结局
- Objective response rate (ORR)(3 months)
- Lymph node derating rate(At time of surgery)
- Disease-free survival (DFS)(24 months)
- Overall survival (OS)(24 months)
- R0 resection rate(At time of surgery)