NCT04819958Unknown不适用
The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Short-term Outcome and Long-term Outcome of Patients With Gastric Cancer
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
The purpose of this study is to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer.
详细描述
A prospective cohort study will be performed to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer. The evaluation parameters are perioperative clinical efficacy, postoperative complications, and 3-year survival and recurrence rates.
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
- •Age from 18 to 80 years
- •Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
- •Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
- •Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
- •Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
- •History of other malignant diseases within the past five years
- •History of unstable angina or myocardial infarction within the past six months
- •History of a cerebrovascular accident within the past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other diseases
- •Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
- •Forced expiratory volume in 1 second (FEV1)<50% of predicted values
- •Inclusion in another clinical trial
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
3-year disease free survival rate
次要结局
- The variation of C-reactive protein(Preoperative 7 days and postoperative 1, 3, and 5 days)
- 3-year recurrence pattern(36 months)
- 3-year overall survival rate(36 months)
- Time to first flatus(30 days)
- Total number of retrieved lymph nodes(One month after surgery)
- Intraoperative morbidity rates(1 day)
- The variation of white blood cell count(Preoperative 7 days and postoperative 1, 3, and 5 days)
- Time to first ambulation(30 days)
- Time to first soft diet(30 days)
- Morbidity rates(30 days)
- Mortality rates(30 days)
- The variation of hemoglobin(Preoperative 7 days and postoperative 1, 3, and 5 days)
- Time to first liquid diet(30 days)
- Duration of postoperative hospital stay(30 days)
研究者
Chang-Ming Huang, Prof.
Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor
Fujian Medical University
研究点 (1)
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