A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Gastric Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Specificity
研究概览
简要总结
The study is a real-world observational clinical study. Patients diagnosed as gastric cancer through histopathology were screened and enrolled. Before anti-tumor treatment, gastroscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in gastric cancer treatment and drug susceptibility outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥ 18 and ≤80;
- •Patients with gastric cancer diagnosed by histopathology;
- •Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment;
- •Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained;
- •Patients who sign the informed consent form, and are able to comply with the study period treatment process.
排除标准
- •Inability to follow the research protocol;
- •Inability to obtain relevant fresh specimens by biopsy/surgery/puncture;
- •Concomitant contraindications to chemotherapy;
- •pregnant or lactating women;
- •Patients deemed inappropriate by investigators.
结局指标
主要结局
Specificity
时间窗: Through study completion, an average of 1 year
Cases in which drug susceptibility results are resistance to the antineoplastic regimen as a percentage of the cases that are ineffective in clinical evaluation
Disease-free survival
时间窗: From date of surgery until the date of first documented recurrence，up to 3 years
An Indicator of efficacy of postoperative adjuvant therapy
Sensitivity
时间窗: Through study completion, an average of 1 year
Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as a percentage of the cases that are effective in clinical evaluation
次要结局
未报告次要终点
研究者
Funan Liu
professor
China Medical University, China