Clinical Efficacy and Safety of Adjuvant Immunotherapy (Tirelizumab) Plus Chemotherapy Versus Adjuvant Chemotherapy Alone in Lymph Node Positive Patients With Gastric Cancer After D2 Radical Resection
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The 1-year DFS rate
研究概览
简要总结
Lymph node positive patients after D2 radical surgery for gastric cancer, who started to be treated at Yixing people's Hospital in April 2021, were selected and enrolled into the study group according to the patients' wishes: immune (tirelizumab) combined with chemotherapy (XELOX regimen) or control group: chemotherapy alone (XELOX regimen). Each enrolled patient signed an informed consent form approved by the ethics committee, signed, and dated. Efficacy and adverse effects were assessed in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 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
- 未提供
研究组 & 干预措施
study group
chemotherapy with oxaliplatin + heroda regimen (oxaliplatin 130mg / m2 D1, heroda tablets 1000mg / m2 bid d1-14, 21d repeated), during which tirelizumab (200mg, q3w) was used. After 6 cycles of chemotherapy, monotherapy with tirelizumab (200 mg, q3w) was maintained until 1 year.
干预措施: tirelizumab (Drug)
study group
chemotherapy with oxaliplatin + heroda regimen (oxaliplatin 130mg / m2 D1, heroda tablets 1000mg / m2 bid d1-14, 21d repeated), during which tirelizumab (200mg, q3w) was used. After 6 cycles of chemotherapy, monotherapy with tirelizumab (200 mg, q3w) was maintained until 1 year.
干预措施: chemotherapy with oxaliplatin + heroda (Drug)
Control group
6 cycles of oxaliplatin + heroda regimen chemotherapy.
干预措施: chemotherapy with oxaliplatin + heroda (Drug)
结局指标
主要结局
The 1-year DFS rate
时间窗: 1 year
within one year from onset
次要结局
未报告次要终点
研究者
Zhou Yan
Chief physician
Yixing People's Hospital