A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 15
- 主要终点
- Pathological complete response
研究概览
简要总结
This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (serplulimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with serplulimab and chemotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 years old, no gender limitation;
- •Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma with cTNM stage II/III，T≥3, N ≥0, M=0；
- •Expected survival of ≥ 3 months;
- •The tumor specimens were PD-L1 positive (CPS ≥ 1)；
- •There is a measurable lesion with the possibility of radical R0 resection after evaluation by doctors；
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Patients informed about the purpose and course of the study and provided a written consent to participate.
排除标准
- •Use of taurine agent within 1 month prior to the first dose of study treatment and throughout the study;
- •Patients with positive HER-2；
- •Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
- •Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
- •Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS) or autoimmune disease or immunosuppressant use；
- •There are patients who may increase the risk of participating in the study and study medication, or other severe, acute and chronic diseases, and are not suitable for participating in the clinical study according to the judgment of the investigator.
研究组 & 干预措施
Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
干预措施: Taurine (Dietary Supplement)
Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
干预措施: Serplulimab (Biological)
Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
干预措施: Serplulimab (Biological)
Taurine + Serplulimab + XELOX
Taurine + Serplulimab + XELOX chemotherapy regimen
干预措施: XELOX regimen (Drug)
Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
干预措施: XELOX regimen (Drug)
Placebo + Serplulimab + XELOX
Taurine placebo + Serplulimab + XELOX chemotherapy regimen
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Pathological complete response
时间窗: Through study completion, Within 1 week after operation
To evaluate the pathologic complete response rate of locally advanced gastric cancer treated with concurrent serplulimab with chemotherapy with or without taurine supplementation.
次要结局
- Major pathological response (MPR)(Through study completion, Within 1 week after operation)
- R0 resection rate(Through study completion, Within 1 week after operation)
- Objective response rate (ORR)(Through study completion, an average of 1 year.)
- Disease-free survival (DFS)(Through study completion, an average of 1 year)
- Event-free survival (EFS)(Through study completion, an average of 1 year)
- Overall survival (OS)(Through study completion, an average of 1 year)
- Quality of life(Through study completion, an average of 1 year])
- Changes in CD8+ T cell infiltration in tumor tissue(1 year)
- Changes in CD8+ T cell death and function(Through study completion, an average of 1 year)
- Safety endpoints(Through study completion, an average of 1 year)