Gastric cancer
Conditions
Interventions
Total gastrectomy group:Total gastrectomy
Proximal gastrectomy group:Proximal gastrectomy
Sponsors
Department of General Surgery, The First Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: ? Patients with clinically and pathologically confirmed locally advanced adenocarcinoma of the upper stomach (upper 1/3 stomach) or adenocarcinoma of the gastroesophageal junction (Siewert types II and III) are clinically classified as t2n+m0 and t3-4an0-3m0, and the staging criteria refer to the eighth edition of AJCC guidelines; ? Age: age = 18 years; ? The tumor diameter was > 4cm before treatment; ? Imaging evaluable lesions according to RECIST 1.1 standard before neoadjuvant therapy (within 28 days); ? Tumor diameter = 4cm (RECIST 1.1 criteria) was assessed after neoadjuvant therapy (within 28 days); ? Patients' response to treatment after neoadjuvant therapy (within 28 days) was CR or pr (RECIST 1.1 criteria); ? ASA score = grade III; ? Laboratory examination met the following conditions: hemoglobin (HB) = 90 g/l, absolute neutrophil count = 3 × 109/l, platelet count (PLT) = 100 × 109/l, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal (ULN), total bilirubin = 1.5 × ULN, serum creatinine (SCR) = 1.5 × ULN, serum albumin (ALB) = 30 g / L; ? Eastern Cooperative Oncology Group (ECoG) score 0-1; ? The expected survival time was = 6 months to determine the research qualification for R0 resection with the purpose of cure; ? Women of childbearing age must have a negative pregnancy test, and must take contraceptive measures during the study period and within 3 months after the last dose to avoid breastfeeding; Male subjects must agree to take contraceptive measures during the study period and within 3 months after the last dose; ? Patients had good organ (including bone marrow) function within 7 days before enrollment; ? Voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: ? Severe mental disorders; ? Pregnant or lactating women; ? Patients with gastric stump cancer and other benign and malignant tumors of the stomach; ? Preoperative imaging examination revealed suspicious enlarged lymph nodes above and below the gastric pylorus; ? Previously received systematic radiotherapy and targeted therapy for gastric / gastroesophageal junction cancer; ? Central nervous system metastasis untreated peripheral neuropathy (>1 grade, according to CTCAE 5.0 criteria); ? Suffering from or suspected of autoimmune diseases; ? Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc; ? Have a history of other malignant tumors in the past five years (except for malignant tumors that are expected to be cured after treatment, including cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, localized prostate cancer, and malignant tumors with an expected 5-year survival rate of > 90% and negligible risk of metastasis or death, such as thyroid cancer); ? Major cardiovascular diseases, such as NYHA grade = II, myocardial infarction and unstable angina pectoris 3 months before enrollment; ? Patients received systemic corticosteroids (> 10mg/d prednisone and other drugs) or other systemic immunosuppressants (such as dexamethasone, cyclophosphamide, methotrexate, thalidomide, etc.) within 2 weeks of enrollment. Topical applications such as ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted; ? Patients undergoing emergency surgery due to gastrointestinal bleeding, perforation, stenosis, etc; ? The patients were vaccinated with live virus vaccine within 4 weeks after enrollment; ? Those who are allergic to the drug ingredients of this study and have known history of allergic diseases or allergic constitution ? Have bleeding tendency, or obvious hemoptysis or other bleeding events (such as gastrointestinal bleeding, hemorrhagic gastric ulcer), or have hereditary or acquired bleeding or thrombophilia tendency (such as hemophilia, coagulation disorders, thrombocytopenia, etc.), or current / long-term thrombolytic or anticoagulant therapy (except aspirin = 100 mg/ day) within 2 months before starting the study treatment; ? Patients who had participated in or were participating in other clinical trials within 4 weeks before enrollment; ? The investigator considered it inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Overall survival rate;2-year Relapse free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative quality of life;Overall complication rate at 30 days postoperatively;pCR rate;Change rate of nutritional indicators (hemoglobin, lymphocyte count, total protein, albumin and body mass);Short term clinical outcomes; | — |
Countries
China
Contacts
Public ContactJIANXIN CUI
Department of General Surgery, The First Medical Center, Chinese PLA General Hospital
Outcome results
None listed