Gastric carcinoma
Conditions
Interventions
experimental group:N-CWS combine Paclitaxel and S1
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary gastric adenocarcinoma with peritoneal metastasis and ascites confirmed by pathology or imaging did not receive chemotherapy or had no disease progression in a short period ( 12 weeks; 5. Patients with sufficient organ and bone marrow function are defined as follows: A) neutrophil count (ANC) >= 1500 / mm3 (1.5 x 10^9 / L); B) platelet count (PLT) >= 100; C) serum creatinine (SCR) = 60 ml / min; D) total bilirubin (BIL) = 9 g / dl (90 g / L); F) AST / SGOT or ALT / SGPT = 2 +, 24-hour urinary protein quantitative display protein must be <= 1g; I) thyroid stimulating hormone (TSH) <= If the level of T3 and T4 is abnormal, T3 and T4 can be selected if the level of T3 and T4 is normal; 6. Women of childbearing age must have taken reliable contraceptive measures, or carry out pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test period and 8 weeks after the last administration of the test drug; 7. The subjects voluntarily joined the study and signed the informed consent, with good compliance and cooperation with treatment and follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following items were not included in this study: 1. Patients who are known to be allergic to the study drug or any of its excipients; 2. Patients who had previously used immunomodulatory drugs within 14 days before signing the informed consent, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other cortical steroids with the same physiological dose of drugs); Three Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood has been completely relieved, adults do not need any intervention) Asthma patients who need bronchodilator for medical intervention can not be included; 4. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (hepatitis C antibody positive patients, HCV-RNA higher than the detection limit of analysis method) or co infection of hepatitis B and hepatitis C; 5. Patients with liver metastasis, lung metastasis, bone metastasis and other organ metastasis; 6. Patients with bloody ascites or inflammatory ascites; 7. Patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above heart failure, and poorly controlled arrhythmias (including QTCF interval > 450 ms for men and > 470 MS for women) within 6 months before entering the study Formula calculation), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 8. Patients with abnormal coagulation function (INR > 1.5 or APTT > 1.5 x ULN), patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy are not suitable for operation; 9. Patients with known hereditary or acquired bleeding and thrombotic tendency, such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc; 10. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Patients with known or history of drug abuse; 12. Patients with other malignant tumors within 5 years; 13. Patients with other serious physical or mental disorders or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, and patients considered unsuitable by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PCR;ORR;OS; | — |
Countries
China
Contacts
Public ContactHuimian Xu
The First Hospital of China Medical University
Outcome results
None listed