Gastric cancer
Conditions
Interventions
Group A:Tigerio + Oxaliplatin
Group B:Tigerio + oxaliplatin + apatinib
Sponsors
Luwan Branch, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients Aged 18 to 75 years, male or female; 2.Patients with local advanced gastric cancer (T3-4Nx +M0) who were diagnosed with gastric adenocarcinoma by histology and/or cytology and underwent D2 radical gastrectomy; 3.ECOG score is 0-1; 4.No prior anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 5.Expected survival >= 6 months; 6.Heart function was good before inclusion, no myocardial infarction occurred within half a year, and hypertension and other coronary diseases were under control; 7.Main organs function normally and meet the following requirements: (1) Routine blood examination should meet the following requirements: 1)HGB >= 90g/L; 2)ANC >=1.5x10^9/L; 3)PLT >=100x10^9/L (2)Biochemical examination should meet the following standards: 1)BIL =50ml/min (Cockcroft-Gault formula) The electrocardiogram was basically normal 4 weeks before inclusion, and no clinically symptomatic heart disease was found; 8.No other uncontrollable benign diseases, such as lung, liver, kidney, or infection, before enrollment; 9.Patients voluntarily participated in this study and signed informed consent (ICF).
Exclusion criteria
Exclusion criteria: 1.Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 2.Previous serious cardiovascular diseases: myocardial ischemia or myocardial infarction above II, poorly controlled arrhythmias (including QTC interval >=450ms for males and >=470ms for females);According to NYHA standard, III-IV cardiac dysfunction, or heart color ultrasound examination indicated left ventricular ejection fraction (LVEF)1.0g); 4.Patients known to be HER2-positive were excluded ( or HER2 boundary result , FISH confirmed positive);Patients with negative and unknown HER2 positivity could be enrolled; 5.The investigator believed that there was a risk of bleeding; 6.Long-term use of antiplatelet drugs such as aspirin and clopidogrel, or anticoagulant drugs such as warfarin; 7.Abnormal coagulation function and bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival of 3 years(3y-DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease-free survival of 1 years(1y-DFS);Disease-free survival of 2 years(2y-DFS); | — |
Countries
China
Contacts
Public ContactQiu Qingqing
Luwan Branch, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed