HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- OS
研究概览
简要总结
Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •histologically proven adenocarcinoma of stomach
- •stage cT3-4N+M0
- •no involvement of esophagus > 3 cm
- •ECOG (Eastern Cooperative Oncology Group) : 0~1
- •no previous chemotherapy or radiotherapy for any malignancy
- •no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
- •Signed the Informed Consent Form
排除标准
- •Serious diseases that are difficult to control
- •Severe hepatic and renal dysfunction
- •Abnormal coagulation
- •The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
结局指标
主要结局
OS
时间窗: 3 years
overall survival
Peritoneal recurrence
时间窗: 3 years
次要结局
- Adverse Events(3 years)
- DFS(3 years)
研究者
Zhixin Cao
Prof
Tongji Hospital