gastric/ gastroesophageal junction adenocarcinoma
Conditions
Interventions
Observational group:PD-1 mab combined with HIPEC and CapeOX chemotherapy
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Pathological diagnosis of gastric cancer; 2) Abdominal metastasis was considered by imaging examination; 3) Age 18-70; 4) ECOG score =1; 5) Normal organ functional reserve: White blood cell count =3.0*10^9/L, absolute neutrophil count =1.5*10^9/L, platelet count =100*10^9/L; Total bilirubin = upper limit of normal value, AST and ALT=3 times upper limit of normal value; Creatinine = upper limit of normal value; 6) HIV negative; In patients with chronic hepatitis B virus (HBV) infection, the viral load is in the normal range during the course of antiviral therapy. Patients with a history of hepatitis C virus (HCV) infection must be treated and cured. Patients with hepatitis C virus infection who are currently receiving treatment are eligible if their hepatitis C viral load is undetectable; 7) PC-I =15 points; 8) Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) History of previous malignant tumors or concurrent malignant tumors of other sites; 2) The presence of non-intraperitoneal metastatic lesions in liver, lung, para-aortic lymph nodes, bone, brain, and adrenal glands; 3) Underwent Cytoreductive Surgery or emergency surgery due to complications such as bleeding, perforation and obstruction; 4) Her-2 was positive by immunohistochemistry or in situ hybridization; 5) Previous history of severe hypersensitivity reaction to any component of other monoclonal antibodies or PD-1 monoclonal antibody injection; 6) Preoperative pathological diagnosis of squamous cell carcinoma or neuroendocrine tumor; 7) Previously received systematic chemotherapy or radiotherapy for gastric adenocarcinoma; 8) Previous treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T lymphocyte-associated protein 4 (CTLA4) receptor; 9) 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 for antiphospholipid syndrome and wegener granulomatosis, sjogren's syndrome, guillain-barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis, etc; 10) Patients with autoimmune related hypothyroidism who received a stable dose of thyroid hormone replacement therapy were eligible to participate in the study; 11) Patients with controlled type 1 diabetes on a stable insulin regimen were eligible to participate in the study; 12) had undergone 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 procedures in the Administrative Measures on the Clinical Application of Medical Technology implemented on May 1, 2009); 13) Received 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; 14) Received systemic corticosteroids (>10 mg/ 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; 15) For patients requiring baseline and subsequent MRI tumor evaluation who have had previous allergic reactions to intravenous contrast media, steroids can be used prophylactically; 16) 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 adrenocortical insufficiency; 17) Patients with previous allogeneic bone marrow transplantation or previous solid organ transplantation; 18) 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; 19) Receive any live vaccine (e.g., vaccines against infectious diseases, such as influenza, chickenpox, etc.) within 4 weeks (28 days) prior to randomization; 20) Active infections, including tuberculosis (clinical diagnosis includes clinical history, physical examination and imagin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survial;PFS;ORR; | — |
Countries
China
Contacts
Public ContactYong Li
Guangdong Provincial People's Hospital
Outcome results
None listed