Status:
UNKNOWN
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
Lead Sponsor:
Tang-Du Hospital
Conditions:
Stage IV Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02291211
Start Date
September 1 2014
End Date
December 1 2016
Last Update
November 14 2014
Active Locations (1)
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1
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Xi'an, Shaanxi, China, 029