Advanced adenocarcinoma of stomach or gastroesophageal junction
Conditions
Interventions
Case series:PD-1 mAb and allogeneic NK cells
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Tumor type: Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histology or cytology, with HER-2 status negative or unknown, previous standard first-line and second-line chemotherapy regimen (fluorouracil drugs, including fluorouracil, capecitabine or tegafur; oxaliplatin or cisplatin; paclitaxel, docetaxel, albumin bound Paclitaxel; irinotecan) Objective: To evaluate the therapeutic effect of anthracycline drugs, including epirubicin and doxorubicin, and to determine the target lesion; 2. Clinical stage: stage IV; 3. Aged 18-75 years old; 4. ECoG score 0-2 points; 5. The expected survival time is more than 3 months; 6. The function of main organs was normal and there was no contraindication of chemotherapy; (1) Blood routine test: HB >= 90g/L; ANC >=1.5x10^9/L; PLT >=75x10^9/L; HB >=90 g/L; ANC >=1.5x10^9/L; PLT >=75x10^9/L; PLT >=75x10^9/L; PLT >=75x10^9/L; PLT >=75x10^9/L; (2) TBIL =50ml / min (calculated according to Cockcroft Gault formula); (3) There was no obvious abnormality in ECG; (4) Coagulation function: activated partial thromboplastin time (APTT) <=1.5 ULN, international standardized ratio <= 1.5 ULN; 7. No other malignant tumor; 8. Eligible fertile patients (male and female) must agree to use reliable contraceptive methods during the trial and at least 90 days after the last medication; the blood or urine pregnancy test of female patients of childbearing age must be negative within 7 days before enrollment; 9. The subjects should give informed consent to the study before the trial, and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. There are chemotherapy contraindications; 2. There was no confirmed adenocarcinoma of stomach or gastroesophageal junction. 3. Received chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the study drug; 4. Received other clinical trials within 4 weeks before the first use of the study drug; 5. Having received major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first use of the study drug; 6. Patients who have received systemic corticosteroids (prednisone > 10mg / day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug, except for the following patients: topical, ocular, intra articular, nasal and inhaled corticosteroids; short-term use of corticosteroids for preventive treatment (e.g. prevention of docetaxel) Allergy to contrast media); 7. The adverse reactions of previous anti-tumor therapy have not recovered to 480ms; acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events above grade III within 6 months; New York Heart Association (NYHA) new functional classification >= II or left ventricular ejection fraction (LVEF) < 50%; uncontrollable hypertension; 13. Patients with active or previous autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); patients with clinically stable autoimmune thyroiditis are excluded; 14. Mental disorder or poor compliance; 15. Pregnant or lactating women; 16. The researchers considered that the subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Progression free survival; | — |
Countries
China
Contacts
Public ContactZhan Xianbao
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed