gastric carcinoma
Conditions
Interventions
Case series:N-CWS combine Paclitaxel and S1
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with primary gastric adenocarcinoma with peritoneal metastasis and ascites who had not received chemotherapy or had no disease progression after short-term (= 1,500/mm3 (1.5 x 10^9/L);B) platelet count (PLT) >= 100,000/mm (100 x 10^9/L); C) hemoglobin (Hb) >= 9 g/dL (90 g/L);D) serum creatinine = 60 ml/min; E) total bilirubin (BIL) = 2+, 24-hour urine protein quantitative display protein must be <= 1g;I) thyroid stimulating hormone (TSH) <= upper normal value (ULN); If the TSH is abnormal, they should be considered the level of T3 and T4. If the T3 and T4 levels are normal, they can be included. 6. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with negative results. They are willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the experimental drug; 7. Subjects volunteered to participate in this study and signed informed consent, with good compliance in treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1.Known allergies to the drug or any of its excipients 2.Previous use of immunomodulatory drugs within 14 days before surgery but not include nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses (i.e., no more than 10 mg/ d prednisone or other corticosteroids of the same drug physiological dose). 3.Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma in childhood were in complete remission and in adulthood without any intervention could be included. Subjects with asthma who needed bronchodilators for medical intervention were excluded. 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 and hcv-rna higher than the lower limit of assay) or co-infection with hepatitis b and c 5.Patients with liver metastasis, lung metastasis, bone metastasis and other organ metastases 6.Patients with bloody ascites or inflammatory ascites 7.Before enrollment in 6 months, the following condition: myocardial infarction, severe/unstable angina, NYHA class above 2 cardiac insufficiency, poor control of cardiac arrhythmias (including QTcF interphase men > 450 ms, women > 470 ms, QTcF interphase Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism). 8.Patients with abnormal coagulation (INR>1.5 or APTT>1.5 × ULN) who are prone to bleeding or who are undergoing thrombolysis or anticoagulation therapy are not suitable for surgery 9.Patients with hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, clotting disorders, thrombocytopenia, and hypersplenism 10.Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 11.Patients with a history of psychiatric drug abuse or drug use 12.Patients with other malignancies within 5 years 13.Patients with other serious physical or mental disorders or laboratory abnormalities that may increase the or interfere the results of the study, and patients that the investigator deems inappropriate for participation in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| the OS rate of 1, 3, 5 years;DFS;ORR; | — |
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;PCR; | — |
Countries
China
Contacts
Public ContactHuimian Xu
The First Hospital of China Medical University
Outcome results
None listed