The First-line Combined Chemotherapy for Advanced Gastric Cancer: A Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Overall survival(OS) . overall survival Overall survival(OS)
研究概览
简要总结
This prospective cohort study aims to observe the efficacy and safety of the first-line combined chemotherapy for advanced gastric cancer(AGC) in Chinese population.
详细描述
- Establish a clinical database for the advanced gastric cancer patients treated with first-line combined chemotherapy in Tongji hospital.
1.1.Data including age, gender, smoking state, karnofsky performance score（KPS）, disease history, clinical stage, primary tumor site, metastasis site, surgery, first-line chemotherapy, therapy after failure of first-line treatment, radiotherapy, toxicity, survival time, the time of free of progress, response were collected.
1.2.The peripheral blood samples were collected for further biomarker reserch. 2. Kaplan-Meier and Cox model will be used to analyze the overall survival(OS) and progression-free survival(PFS) of advanced gastric cancer. 3. Extract Deoxyribonucleic acid（DNA） from the the peripheral blood and research biomarkers related to the first-line combined chemotherapy for AGC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma;
- •Unresectable locally advanced, or recurrent, or metastasis disease；
- •Chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed.
- •Life expectancy of at least 3 months;
- •ECOG score 0-2;
- •Voluntarily signed the informed consent.
- •Exclusion criteria:
- •Previously treated with first-line chemotherapy;
- •First-line chemotherapy with single drug.
排除标准
- 未提供
结局指标
主要结局
Overall survival(OS) . overall survival Overall survival(OS)
时间窗: From date of enrollment until the date of death from any cause, assessed up to 60 months
次要结局
- Progression-free survival(PFS)(From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Objective response rate(ORR)(The sum of complete remission (CR) rate and partial remission (PR) rate. Response will be measured through first-line treatment completion, up to 1 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Through first-line treatment completion,up to 24 weeks.)
- Disease control rate(DCR)(The sum of CR rate, PR rate and stable disease(SD) rate. Response will be measured through first-line treatment completion, up to 1 year)
研究者
Xianglin Yuan
Professor, Chief Physician
Huazhong University of Science and Technology