SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tang-Du Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 18 ≤ age ≤ 70 years old

• Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted 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:

• History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin

• Hemoglobin<90g/L

• 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

• Participate in other clinical trial before the start of this trial

• Patient compliance is bad or researchers believe that patients are not suitable for this treatment

• Known to have active hepatitis patients