NCT07149181尚未招募4 期
A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as Postoperative Adjuvant Regimens in Patients With Resectable Gastric Cancer/Adenocarcinoma of the Esophagogastric Junction After Radical Surgery
Liaoning Cancer Hospital & Institute0 个研究点目标入组 1,000 人开始时间: 2025年8月31日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease.
研究概览
简要总结
This study is to evaluate the efficacy and safety of chemotherapy combined with or without immunotherapy as postoperative adjuvant regimens in patients with resectable gastric cancer/adenocarcinoma of the esophagogastric junction after radical surgery
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, gender not restricted;
- •Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
- •HER2 overexpression or amplification results are negative;
- •After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.
排除标准
- •Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types;
- •Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency;
- •Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding;
- •Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated);
- •Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;
研究组 & 干预措施
SOX or XELOX with immunotherapy
Experimental
干预措施: SOX plus PD-1 inhibitor (Drug)
SOX or XELOX
Active Comparator
干预措施: SOX Chemotherapy (Drug)
结局指标
主要结局
Compare the differences in the DFS rates between the two groups of subjects, DFS (Disease-Free Survival, which is the time from the start of postoperative adjuvant therapy until the first occurrence of recurrent disease.
时间窗: The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years
次要结局
- Compare the differences in the OS rates between the two groups of subjects, OS (Overall Survival, which refers to the time from the start of postoperative adjuvant therapy until death due to any cause)(The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years)
- The Adverse Events of anti-PD1/PDL1 monoclonal antibody combined with chemotherapy versus chemotherapy in postoperative adjuvant treatment for gastric cancer/adenocarcinoma of the esophagogastric junction(The observation period starts from the time the postoperative adjuvant therapy begins and lasts for at least 2 years)
研究者
Zheng Guoliang
Vice Offices Director
Liaoning Cancer Hospital & Institute
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