Gastric cancer
Conditions
Interventions
Group A :Cardonilizumab and COX-2 inhibitors combined with capecitabine and oxaliplatin (XELOX) applied in the perioperative period
Group B:Capecitabine and oxaliplatin (XELOX) applied in the perioperative period
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent; 2. Aged>=18 and=90g/L, in order to achieve this standard, patients can receive blood transfusion treatment; b. Absolute neutrophil count >=1.5x10^9/L; c. Platelet count >=100x10^9/L; d. aspartate or alanine aminotransferase <= 2.5 times the upper limit; e. Alkaline phosphatase <= 2.5 times the upper limit of normal (ULN); f. Thyroid stimulating hormone (TSH) <=1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be included in the group)
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) or unresectable gastric cancer as determined by the investigator; 2. Previous systemic treatment for gastric cancer; 3. Previous history of allergy to cardonilizumab, celecoxib, capecitabine, oxaliplatin; 4. Received any of the following treatments: a. Previous anti-PD-1 or anti-PD-L1 antibody therapy; b. Received any investigational drug treatment within 4 weeks prior to initial drug use; c. Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; d. Receiving the last dose of anticancer therapy (including radiation therapy) within 4 weeks prior to the first use of the investigational drug; e. Subjects requiring systemic treatment with corticosteroids (>10mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to initial use of the study drug; f. Received an anti-tumor vaccine or a live vaccine within 4 weeks prior to the first administration of the investigational drug; g. Received major surgery or external injury within 4 weeks prior to the first use of the study drug; History of other malignant diseases within 5.5 years; 6. Patients with an active autoimmune disease, a history of autoimmune disease, other than vitiligo or asthma/allergies from childhood that have recovered and do not require any intervention as adults; Autoimmune mediated hypothyroidism is treated with a stable dose of thyroid replacement hormone and type I diabetes with a stable dose of insulin; A history of immunodeficiency, including HIV testing positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 7. The subject has cardiovascular clinical symptoms or diseases that are not well controlled; 8. Severe infections (CTCAE> Grade 2), such as severe pneumonia requiring hospitalization, bacteremia, and infection complications, occurred 4 weeks before the first use of the study drug; Baseline lung imaging indicated the presence of active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except in cases of prophylactic antibiotic use. 9. History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia; 10. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment; 11. Pregnant or lactating women; 12. Severe mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;One-year overall survival rate;Three-year overall survival rate;One-year disease free survival rate;Three-year disease free survival rate;ORR;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactShirong CAI
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed