NCT06250894招募中2 期
A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年3月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
The purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.
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
- •Age 18-70, male and female.
- •Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III.
- •No previous anti-tumor treatment.
- •ECOG score was 0-
- •Expected survival of ≥ 6 months
- •Adequate organ reserve function.
排除标准
- •Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years.
- •Known Her-2 positive( IHC 3+ or FISH positve).
- •Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody
- •Severe allergic reaction to monoclonal antibody.
- •Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study
- •Known endoscopic signs of active bleeding from the lesion
研究组 & 干预措施
Neoadjuvant immunotherapy-chemoradiotherapy
Experimental
This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation.
generic name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation
干预措施: PD-1inhibitor (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: 10 days after operation
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
次要结局
- Disease-Free-Survival (DFS)(Through study completion, an average of 1 year)
- Objective response rate (ORR)(6 months after the recruitment of the last subject.)
- Overall survival (OS)(Through study completion, an average of 1 year)
- Number of participants with AEs (Adverse Events)(Through study completion, an average of 1 year)
- Major pathologic response (MPR)(10 days after operation)
研究者
研究点 (1)
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