The Relationship Between Complement C3 Depletion and Metastatic Gastric Cancer: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.
详细描述
The complement system plays an important role in the development of digestive malignancies. The complement C3 is the point of convergence for the three complement activation pathways. However, the concrete effect of C3 in the development of gastric cancer is still obscured. This study is designed to explore whether complement C3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer.
This study is designed as a prospective cohort study and included consecutively treated patients. The perioperative plasma value of complement components, such as C3, C4, and CH50, are detected to explore the incidence rate of complement depletion. All enrolled patients are divided into two groups mainly according to the levels of preoperative C3 levels (C3 depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges.
This study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.
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
- •Pathological diagnosis of gastric adenocarcinoma
- •Radical operation and adjuvant chemotherapy endurable
- •Informed consent approved
排除标准
- •Age <18 or >75 years old
- •Pregnancy or lactating woman
- •Any primary diagnosis other than gastric cancer
- •Confirmed complement deficiency due to immunity dysfunction or other disease
- •Required blood transfusion, plasmapheresis, or emergent operation
研究组 & 干预措施
C3 Depletion
Patients with persistent low-level of complement C3 within the perioperative period would be assigned into this main observational group. After a careful multidisciplinary treatment (MDT) discussion, a radical operation with gastrectomy plus D2 lymphadenectomy would be performed, followed by an adjuvant chemotherapy if required. Generally, SOX chemo regimen (S-1+Oxaliplatin) would be first considered for the candidates.
干预措施: gastrectomy plus D2 lymphadenectomy (Procedure)
C3 Depletion
Patients with persistent low-level of complement C3 within the perioperative period would be assigned into this main observational group. After a careful multidisciplinary treatment (MDT) discussion, a radical operation with gastrectomy plus D2 lymphadenectomy would be performed, followed by an adjuvant chemotherapy if required. Generally, SOX chemo regimen (S-1+Oxaliplatin) would be first considered for the candidates.
干预措施: S-1+Oxaliplatin (Drug)
Non-C3 depletion
Patients with normal plasma values of complement C3 within the perioperative period would be assigned into this control group. Those patients would undergo the same decision making process to determine the final treatment plan.
干预措施: gastrectomy plus D2 lymphadenectomy (Procedure)
Non-C3 depletion
Patients with normal plasma values of complement C3 within the perioperative period would be assigned into this control group. Those patients would undergo the same decision making process to determine the final treatment plan.
干预措施: S-1+Oxaliplatin (Drug)
结局指标
主要结局
Overall Survival
时间窗: one year after surgery
1-year overall survival (OS) would be regarded as primary endpoint of this study.
Disease-Free Survival
时间窗: One year after surgery
1-year disease-free survival (DFS) would be also regarded as primary endpoint of this study.
次要结局
- Length of hospital stay(an expected average of 4 weeks after admission)
- Early complications(within 30 days after a radical operation)
- Expenditure of hospitalization(an expected average of 4 weeks after admission)
研究者
Yulong He
Director of Center of Gastrointestinal Surgery
First Affiliated Hospital, Sun Yat-Sen University