Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- PFS: Progression Free Survival
研究概览
简要总结
This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
- •Didn't received any prior systemic chemotherapy
- •Signed informed consent
排除标准
- •History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- •Pregnancy or lactation women,
- •Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
- •Inadequate organ function which is defined as below:
- •Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
- •Symptomatic peripheral neuropathy
- •Receiving a concomitant treatment with other fluoropyrimidines
- •Fluoropyrimidines (DPD) congenital absence
- •Other Situations which physicians suggesting are inadaptable for enrollment
研究组 & 干预措施
Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
干预措施: S-1 (Drug)
Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
干预措施: oxaliplatin (Drug)
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
干预措施: S-1 (Drug)
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
干预措施: oxaliplatin (Drug)
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
干预措施: Hyperthermic Intraperitoneal (Device)
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
干预措施: Paclitaxel (Drug)
结局指标
主要结局
PFS: Progression Free Survival
时间窗: through study completion, an average of 1 year
time from enrollment to disease progression or death
次要结局
- OS:overall survival(3 years)
- Safety(3 years)
研究者
Wang Kuan, M.D.Prof
Professor
Harbin Medical University