Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Experimental group:Navulio + chemotherapy
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have a full understanding of this research and voluntarily sign the Informed Consent Form (ICF); 2. Histologically diagnosed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, and at the same time meet the following conditions: clinical staging according to endoscopic ultrasonography and/or enhanced CT/MRI examination, staging standards refer to AJCC 8th edition cancer staging, include patients with the following clinical stages; (1) T2, N1-3, M0; (2) T3, N0-3, M0; (3) T4a, N0-3, M0; 3. Aged 18 to 75 years, no gender restrictions; 4. ECOG score 0-1 points; 5. Expected survival period >= 3 months; 6. Female patients who meet the following criteria 7 days before enrollment are eligible to be enrolled and participate in the study: (1) Women who are infertile (such as physically unable to conceive) and who meet any of the following conditions: have undergone hysterectomy, have undergone bilateral oophorectomy (oophorectomy), have undergone bilateral tubal ligation, or postmenopausal (total duration of menopause >= 1 year); (2) Have fertility, have a negative serum pregnancy test at the time of screening (within 7 days before the first dose of the study drug), and take adequate contraceptive measures from before entering the study and throughout the study period until 60 days after the last dose of the study drug. Adequate contraception used consistently in accordance with the contraceptive product's directions and the doctor's instructions is defined as follows: 1) IUDs with proven contraceptive failure rates of less than 1% per year. Double barrier contraception refers to condoms with spermicidal jelly, foam, suppository or film; 2) Contraceptive film with spermicide; 3) Male condoms and contraceptive films.
Exclusion criteria
Exclusion criteria: 1. A history of severe hypersensitivity reactions to other monoclonal antibodies or any component of Nivolumab injection. 2. Preoperative pathological diagnosis of squamous cell carcinoma or neuroendocrine tumor. 3. Received systemic chemotherapy or radiotherapy for gastric adenocarcinoma in the past. 4. Suffering from other malignant tumors except gastric cancer within 5 years before enrollment, malignant tumors (eg, adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated with curative intent surgery) with negligible risk of metastasis or death (eg, expected 5-year OS >90%) and expected to have a curative outcome after treatment are excluded. 5. Received treatment for PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor in the past. 6. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis, etc.; patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone replacement therapy are eligible to participate in this study; patients with controlled type 1 diabetes on a stable insulin regimen were eligible to participate in this study. 7. Have undergone major surgery within 4 weeks before enrollment or have not fully recovered from previous surgery (The definition of major surgical operation refers to the Class 3 and Class 4 surgeries stipulated in the ''Administrative Measures for the Clinical Application of Medical Technology'' implemented on May 1, 2009). 8. Receive systemic immunostimulatory drug treatment (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is shorter). 9. Receive systemic corticosteroids (>10 mg/d prednisone equivalent) or other systemic immunosuppressants within 2 weeks before randomization (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] drugs). Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted. Prophylactic steroids can be used in patients with a history of hypersensitivity to intravenous contrast media requiring baseline and follow-up MRI tumor assessments. Inhaled corticosteroids are permitted for chronic obstructive pulmonary disease, corticosteroids (eg, fludrocortisone) for orthostatic hypotension, and low-dose corticosteroids for maintenance adrenal insufficiency. 10. Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation. 11. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (ie, bronchiolitis obliterans), history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening. 12. Any live vaccines (eg, vaccines against infectious diseases such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks (28 days) prior to randomization. 13. Active infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radical resection rate;Objective response rate;Recurrence-free survival ;Overall survival;The incidence of adverse events;Incidence of perioperative complications; | — |
Countries
China
Contacts
Public ContactWang Junjiang
Guangdong Provincial People's Hospital
Outcome results
None listed