A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- chemotherapy regimen
研究概览
简要总结
This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.
Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
- •The informed consent form is signed.
- •A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
- •ECOG performance status is 0, 1 or
- •The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
- •The patient is aged≥18
排除标准
- •The patient is known to be allergic to any study drug.
- •The patient is recruited in other clinical study or is planned to participate into other clinical study.
- •The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).
研究组 & 干预措施
chemotherapy
Eligible patients will accept generalized chemotherapy according to the investigator's assessment.
干预措施: Clinical chemo-drugs (Drug)
结局指标
主要结局
chemotherapy regimen
时间窗: 2 months
To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China
次要结局
- overall survival(2 months)
- quality of life(6 weeks)
- treatment expense(2 months)
研究者
Shen Lin
chief of department of GI oncology
Peking University