A Real World Study of the Treatment of Locally-inoperable Advanced or Advanced Metastatic Gastric Adenocarcinoma With Huachansu
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
To evaluate the efficacy and safety of huachansu oral preparation in the treatment of inoperable locally advanced or advanced metastatic gastric adenocarcinoma, including gastric esophageal adenocarcinoma.
详细描述
In this multicenter, controlled, retrospective, real-world study, the original medical records of participants diagnosed with inoperable locally advanced or advanced metastatic gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) receive treatment in research centers from January 1, 2014 to December 31, 2019 were collected. To evaluate the efficacy and safety of oral huachansu in the systematic treatment of locally advanced or advanced metastatic gastric adenocarcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients who meet all the following criteria are included in the study:
- •Diagnosed with gastric adenocarcinoma (including gastric esophageal junction adenocarcinoma) by histopathology or cytology at the enrolled centers From January 1, 2014 to December 31,
- •Stage of disease (clinical or pathological stage) is locally advanced or advanced (stage IIIB-IV) .
- •The doctor judged that the tumor tissue was unresectable.
- •At least two medical records.
- •At least one huachansu oral preparation (tablet, capsule) was used during treatment (observation group only) .
排除标准
- •Patients who meet any of the following criteria are not allowed to enter the test:
- •Lack of clinical data related to important research indicators (survival).
- •Refusal to cooperate with follow-up.
结局指标
主要结局
OS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
overall survival
AE;SAE
时间窗: 1 year, year 1
adverse event;Serious Adverse Event
次要结局
- ADR;SADR(1 year, year 1)