Predicting Treatment Response to Immunotherapy Combined with Chemotherapy in Advanced Gastric/gastroesophageal Junction Cancer Based on the Multi-omics Information During Tumor Evolution.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Objective Best Tumor Response
研究概览
简要总结
In this project, based on the information of advanced gastric/gastroesophageal junction cancer in evolution under immunotherapy combined with chemotherapy treatment, we will integrate multi-omics dynamic data to identify essential features that correlate to therapeutic effects of immunotherapy therapy, screen potential molecular markers/dominant microbiota for predicting the efficacy of immunotherapy and establish a multimodal predictive model for patients that benefit from immunotherapy. Our project could provide evidence to predict response to immunotherapy for patients with advanced gastric/gastroesophageal junction cancer and potentially optimize the clinical decision-making about therapy for advanced gastric/gastroesophageal junction cancer.
详细描述
Main objective: to extract and identify multi omics information tags related to the efficacy of immunotherapy for advanced gastric / gastroesophageal junction cancer
Secondary objective: to construct and validate the efficacy prediction model of chemotherapy combined with immunotherapy for gastric cancer, in order to optimize the scheme decision of advanced gastric cancer treatment
Exploratory purpose: to screen potential molecular markers / dominant flora for predicting the efficacy of immunotherapy in patients with advanced gastric / gastroesophageal junction cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Objective Best Tumor Response
时间窗: 12 months
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Overall Survival
时间窗: 60 months
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
次要结局
- Progression-free Survival(36 months)
研究者
Xiangdong Cheng
Professor
Zhejiang Cancer Hospital