NCT03987815Unknown2 期
Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Major pathologic response
研究概览
简要总结
This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma
- •Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
- •ECOG performance 0 or 1
- •Age 19 years or older
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
Study Arm
Experimental
Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles
干预措施: Nivolumab (Drug)
结局指标
主要结局
Major pathologic response
时间窗: 2 months
Viable tumor comprised ≤ 10% of resected tumor specimens
次要结局
- Objective response rate (ORR)(2 months)
- Positron Emission Tomography (PET)-CT response(2 months)
- Progression-free survival (PFS)(24 months)
- Overall survival (OS)(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical studies confirming the usefulness of preoperative nivolumab treatment for operable esophageal squamous cell carcinomaNeoplasmsKCT0004189Samsung Medical Center20
终止
2 期
Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a MelanomaMelanomaNCT03259425University of Utah7
已完成
2 期
Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin LymphomaCoexisting Medical ConditionsHodgkin LymphomaNCT03580408The Lymphoma Academic Research Organisation64
已完成
2 期
Nivolumab Combined With Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT03984357Sun Yat-sen University152
进行中（未招募）
1 期
A Study of Nivolumab and Nivolumab Combinations in Recurrent and Metastatic Colon CancerEUCTR2013-003939-30-BEBristol-Myers Squibb International Corporation375