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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 plus cisplatin HIPEC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1 plus cisplatin HIPEC | Drug | Using cisplatin in HIPEC plus oral S-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS: Progression Free Survival | from randomization to disease progression or death | 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Known to have abdominal viscera metastasis of gastric cancer patients
Inadequate hematopoietic function which is defined as below:
Inadequate hepatic or renal function which is defined as below:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helong Zhang, Professor | Contact | 029-87777225 | cnxazhl@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Helong Zhang, Professor | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 029 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
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| 2 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |