Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS: Progression Free Survival
研究概览
简要总结
This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)
详细描述
This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age ≤ 70 years old
- •Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
- •The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- •Having given written informed consent prior to any procedure related to the study
- •Expected survival time ≥3 months
排除标准
- •Known to have abdominal viscera metastasis of gastric cancer patients
- •Inadequate hematopoietic function which is defined as below:
- •white blood cell (WBC) less than 3,500/mm^3
- •absolute neutrophil count (ANC) less than 1,500/mm^3
- •platelets less than 80,000/mm^3
- •Inadequate hepatic or renal function which is defined as below:
- •serum bilirubin greater than 2 times the upper limit of normal range
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
- •blood creatinine level greater than 1.5 times ULN,Creatinine clearance < 60ml/min
- •Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
- •Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
- •Psychiatric disorder or symptom that makes participation of the patient difficult
- •Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
- •Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
- •Known DPD deficiency
- •Have the history of allograft transplantation
- •Conducted the autologous bone marrow transplantation in 4 weeks
- •Participate in other clinical trial before the start of this trial in 4 weeks
- •Patient compliance is bad or researchers believe that patients are not suitable for this treatment
- •Known to have active hepatitis patients
- •HER-2-positive patients (ICH3+or FISH+)
- •History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
研究组 & 干预措施
S-1 plus cisplatin HIPEC
8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.
干预措施: S-1 plus cisplatin HIPEC (Drug)
结局指标
主要结局
PFS: Progression Free Survival
时间窗: 2 years
from randomization to disease progression or death
次要结局
- OS: Overall Survival(5 years)
- Safety as measured by recording the subjects' Adverse Events from randomization to termination(2 years)