Stage IV Gastric Cancer
Conditions
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 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.
Interventions
DRUGS-1 plus cisplatin HIPEC
Using cisplatin in HIPEC plus oral S-1
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS: Progression Free Survival | 2 years | from randomization to disease progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS: Overall Survival | 5 years | from randomization to death from any cause |
| Safety as measured by recording the subjects' Adverse Events from randomization to termination | 2 years | Record the subjects' AEs from randomization to termination |
Countries
China
Contacts
Primary ContactHelong Zhang, Professor
Outcome results
None listed