Stomach cancer
Conditions
Interventions
Experimental group:Cadunilimab + FLOT
Sponsors
The First Affiliated Hospital of the Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to join the study and sign the informed consent form; 2. Aged 18-75 years old (calculated on the date of signing informed consent), both male and female; 3. Advanced gastric adenocarcinoma confirmed by histology/cytology and HER-2 negative by IHC/FISH detection (HER2 positive definition: HER2 IHC 2+/FISH positive, or IHC 3+, but not IHC 0 or 1+/FISH positive); 4. Have not received disease-related treatment in the past (including but not limited to radiotherapy, chemotherapy, targeted therapy and immunotherapy); 5. ECOG score: 0-1; 6. According to RECIST v1.1 standard, there is at least one assessable lesion; 7. Good cardiac function, no myocardial infarction in the past six months, controllable hypertension and other coronary heart disease, no serious infection; 8. The functions of important organs meet the following requirements: (1) Absolute neutrophil count >= 1.5 x 10^9/L; (2) Leukocyte >= 4.0 x 10^9/L; (3) Platelet >= 90 x 10^9/L; (4) Erythrin >= 80 g/L; (5) Serum albumin >= 30 g/L; (6) Thyroid stimulating hormone (TSH) <= 1 x ULN (in case of abnormality, the levels of FT3 and FT4 should be investigated at the same time. If the levels of FT3 and FT4 are normal, they can be included); (7) Total serum bilirubin <= 1 x ULN; (8) ALT and AST <= 3 x ULN; (9) AKP <= 2.5 x ULN (known bone metastasis <= 5 x ULN); (10) Serum creatinine <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Those with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type I diabetes patients who are allowed to be included in the group to receive insulin therapy with a stabilizing agent, hypothyroidism patients who only need hormone replacement therapy, and skin diseases that do not require systemic treatment and do not have acute exacerbation within 1 year before the screening period (such as eczema, vitiligo, or cowhide moss); 2. Subjects who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones for more than 10 days) or other immunosuppressants within 1 month before screening. In the absence of active autoimmune diseases, inhaled or local use of corticosteroids and adrenal hormone replacement therapy with a dose 1.5 or prothrombin time (PT) > ULN+4 seconds), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment, and the preventive use of low-dose aspirin and low-molecular-weight heparin is allowed; 13. Active infection or fever of unknown cause within 7 days before medication 38.5 ?, or white blood cell count at baseline > 15 x 10^9/L 14. Suffer from congenital or acquired immune deficiency (such as HIV infection); Or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA 500 IU/ml; hepatitis C reference: HCV antibody positive and upper limit of normal HCV copy number); 15. Other malignant tumors (except for the cured skin basal cell carcinoma and cervical carcinoma in situ) within the past three years or at the same time; 16. Live vaccine should be inoculated less than 4 weeks before the study me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radical (RO) resection rate after conversion therapy;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;disease control rate; | — |
Countries
China
Contacts
Public ContactLi Jipeng
The First Affiliated Hospital of the Air Force Medical University
Outcome results
None listed