locally advanced upper gastric cancer
Conditions
Interventions
Proximal radical gastrectomy group:proximal gastric radical surgery
Total radical gastrectomy group:total radical gastrectomy
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily joined the study and were able to sign the informed consent with good compliance; 2.Age 18-75 years old (at the time of signing the informed consent), both male and female; 3.Histologically and/or cytologically confirmed upper gastric carcinoma (adenocarcinoma), locally advanced according to AJCC Edition 8 criteria, cT3-4 or N+M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary) , and consent to neoadjuvant therapy. Investigators assessed the lesion as resectable or potentially resectable; 4.Have not received systematic treatment for the current disease, including anti-tumor chemoradiotherapy/immunotherapy; 5.ECOG score 0-1; 6.Expected survival =6 months; 7.Preoperative chest, abdominal, pelvic CT or PET-CT to exclude distant metastasis; 8. Major organ functions are good and meet the following standards: 1) Blood routine examination (without blood transfusion or use of hematopoietic growth factors within 14 days): Hemoglobin (Hb) >= 90g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelets (PLT) >= 80×10^9/L; 2) Biochemical examination: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 60mL/min; 3) Coagulation function: Activated partial thromboplastin time (APTT), International normalized ratio (INR), Prothrombin time (PT) = 50%; 5) Clinically determined by the physician to have sufficient organ function; 9. Subjects with reproductive capacity must use appropriate contraception during the study and for 120 days after the study ends, and must have a negative serum pregnancy test within 7 days prior to enrollment, and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1.Other malignant diseases other than gastric cancer diagnosed within 5 years prior to initial treatment(excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radical resection of carcinoma in situ) ; 2.The tumor lesion has a bleeding tendency (such as active ulcer tumor lesion with positive fecal occult blood test, history of hematemesis or black stool within 2 months before signing the informed consent, high risk of massive gastrointestinal bleeding assesed by the researcher) or received blood transfusion treatment 4 weeks before treatment; 3.Inability to take oral medication; 4.Is participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 5.Previously received the following therapies: anti-HER2, anti-PD-1, anti-PD-L1 drugs, anti-PD-L2 drugs or drugs targeting another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 6.Systemic therapy with immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) received within 2 weeks before the first administration; 7.An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 8.Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (= grade 2; 12.History of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13.Subjects with active hepatitis B or C (HBsAg positive with HBV DNA titers higher than the upper limit of normal; HCVAb positive and HCV RNA titer higher than the upper limit of normal); 14.Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted. 15.Pregnant or lactating women; 16.With any serious or uncontrolled systemic disease, such as: 1) The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above ? degree, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade >= 2 chronic heart failure; 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; 4) Long-term uncontrol of hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5) There is a history o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Disease-free survival (DFS);R0 resection rate;Overall Survival (OS);Incidence of adverse reactions;nutritional status;quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathologic response (MPR); | — |
Countries
China
Contacts
Public ContactWang Guihua
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed