gastric/gastroesophageal junction carcinoma
Conditions
Interventions
Experimental Group:Toripalimab injection (JS001) combined with capecitabine and oxaliplatin
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed an informed consent form (ICF); 2. Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histology and meeting the following conditions: Clinical staging was performed according to endoscopic ultrasound and/or enhanced CT/MRI examination. The staging criteria were based on AJCC 8th edition cancer staging, including patients with the following clinical staging: T2, N1-3, M0 / T3, N0-3, M0 / T4a, N0-3, M0; 3. Aged from 18 to 75 years, no gender limit; 4. ECOG score 0-1; 5. Expected survival >=3 months; 6. Women who met the following criteria 7 days before enrollment were eligible for inclusion and participation in the study: Women who were infertile (e.g., physically unable to conceive), women who met any of the following criteria: (1) Having undergone hysterectomy, bilateral oophorectomy (oophorectomy), bilateral tubal ligation, or postmenopause (total duration of menopause >=1 year); (2) Be fertile, have a negative serum pregnancy test at the time of screening (within 7 days before the first dose of study drug), and use adequate contraception from the time of entry and throughout the study period until 60 days after the last dose of study drug. Continuous adequate contraceptive use according to the product's instructions and the doctor's instructions was defined as follows: IUD with a proven contraceptive failure rate of less than 1% per year. Double barrier contraception refers to condoms with spermicide gel, foam, suppository or film; Or a contraceptive film with spermicide; Or condoms and membranes for men.
Exclusion criteria
Exclusion criteria: 1. Previous history of severe hypersensitivity reaction to any component of other monoclonal antibodies or triplimumab injection (JS001); 2. Preoperative pathological diagnosis of squamous cell carcinoma or neuroendocrine tumor; 3. Previously received systematic chemotherapy or radiotherapy for gastric adenocarcinoma; 4. Malignancies other than gastric cancer that had a negligible risk of metastasis or death (e.g., expected 5-year OS>90%) within 5 years before enrollment and for which a radical outcome was expected after treatment were excluded (e.g., adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated for radical purposes, ductal carcinoma in situ treated for radical purposes); 5. Previous treatment targeting the PD-1 receptor or its ligand PD-L1 or the cytotoxic T lymphocyte-associated protein 4(CTLA4) receptor; 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 antiholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, patients with autoimmune related hypothyroidism, such as vasculitis or glomerulonephritis, receiving a stable dose of thyroid hormone replacement therapy were eligible for this study; patients with controlled type 1 diabetes on a stable insulin regimen were eligible to participate in the study; 7. Had a major surgical operation or had not fully recovered from a previous operation within 4 weeks prior to enrollment (major surgical operation is defined according to Grade 3 and 4 operations in the Administrative Measures on the Clinical Application of Medical Technology implemented on May 1, 2009); 8. Receive systemic immune-stimulating drugs (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drugs, whichever is shorter; 9. Received systemic corticosteroids (>10mg/ day prednisone equivalent) or other systemic immunosuppressants (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs [anti-TNF]) within 2 weeks prior to randomization. Topical, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted. Prophylactic steroids may be used in patients requiring baseline and subsequent MRI tumor evaluation who have had previous allergic reactions to intravenous contrast media. Allow the use of inhaled corticosteroids for chronic obstructive pulmonary disease, hydrochloric corticosteroids (e.g., fludrocortisone) for orthostatic hypotension, and low-dose corticosteroid maintenance for adrenal insufficiency; 10. Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation; 11. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (i.e., bronchiolitis obliterans), history of idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening; 12. Receive any live vaccine (e.g., vaccines against infectious diseases, such as influenza, chickenpox, etc.) within 4 weeks (28 days) prior to randomization; 13. Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB testing according to local medical
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Resection rate;Objective response rate;Perioperative complication rate;Recurrence-free survival;Overall survival;Safety and tolerability of combined chemotherapy with tririplizumab injection (JS001);Efficacy prediction biomarkers; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactLi Yong
Guangdong Provincial People's Hospital
Outcome results
None listed