The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 主要终点
- TRG (Tumor Regression Grading)
研究概览
简要总结
This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.
详细描述
In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75, male and female.
- •ECOG score was 0-
- •Diagnosis of adenocarcinoma in the gastroesophageal junction.
- •Initial treatment of locally advanced patients (cT3-4 or N+, and M0).
- •The estimated survival time will be more than 12 months.
- •Adequate organ reserve function.
- •agree to join the group, willing to cooperate with clinical research, and sign the informed consent.
排除标准
- •Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.
- •Immunosuppressive drugs were used within 4 weeks before admission.
- •Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications.
- •In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.
研究组 & 干预措施
Combination of toripalimab with preoperative chemoradiotherapy
This is a one arm study, enrolled locally advanced EGJ patients will receive toripalimab and combined with preoperative chemoradiotherapy and operation.
generic name：PD-1 dosage form：Injection dosage：240mg (6ml) frequency：every 3 weeks duration：4 times before operation and 4 times after operation
干预措施: PD-1 (Drug)
结局指标
主要结局
TRG (Tumor Regression Grading)
时间窗: 10 days after operation
The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.
次要结局
- Number of participants with AEs (Adverse Events)(Through study completion, an average of 1 year)
- LC (Local Control)(Through study completion, an average of 1 year)
- DFS (Disease Free Survival)(Through study completion, an average of 1 year)
研究者
Ziyu Li, MD
The director of ward 1 of gastrointestinal tumor center
Peking University