A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer

Tang-Du Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2023年8月1日最近更新: 2023年11月8日

适应症

干预措施

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: Overall survival (OS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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 (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab 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: Single (Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 or older, no gender limitation;
•Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
•Expected survival of ≥ 3 months;
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
•At least one measurable lesion outside the stomach (RECIST 1.1);
•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 randomization on this study;
•Patients received prior systemic therapy for gastric cancer;
•Patients with operable gastric cancer;
•Patients with positive HER-2 and willing to receive herceptin treatment;
•Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
•Patients with active autoimmune disease that has required systemic treatment in past 2 years;
•Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
•Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
•Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
•Other conditions that the investigator thinks are not suitable to participate in this clinical trial.