S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Conditions
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Stage IV Gastric Cancer

Intervention / Treatment
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* Drug: S-1 plus cisplatin HIPEC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-1 plus cisplatin HIPEC<br>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. | Drug: S-1 plus cisplatin HIPEC<br>* Using cisplatin in HIPEC plus oral S-1<br>* Other names: hyperthermic intraperitoneal chemoperfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS: Progression Free Survival | from randomization to disease progression or death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS: Overall Survival | from randomization to death from any cause | 5 years | 
| Safety as measured by recording the subjects' Adverse Events from randomization to termination | Record the subjects' AEs from randomization to termination | 2 years |