Gastric cancer
Conditions
Interventions
experimental group:Chemotherapy combined with trastuzumab
Sponsors
The First Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old; 2. performance status (PS) of 0 to 2; 3. Patients who are confirmed HER2+ GC or GEJ by pathological histology ,T2-4 and/or N+M0; 4. Without the history of anti-tumor therapy including Radiotherapy, chemotherapy, targeted therapy, immunotherapy; 5. WBC >=3.0 x 10^9/L and ANC >=2.0 x 10^9/L; Platelets >=100 x 10^9/L; Bilirubin =60ml/min or >=50 ml/min by EDTA creatinine clearance; 6. Written informed consent; 7. Good compliance, the family agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. With other malignant tumor, except those that have been cured or stabilized; 2. Women who is pregnant or breastfeeding; 3. Participated in clinical trials of other drugs within one month; 4. A variety of factors (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction) that affect oral medications; 5. Any bleeding event of severe grade up to 3 or more in CTCAE4.0 within 4 weeks prior to screening; 6. Patients with a known history of central nervous system metastasis or central nervous system metastasis were screened; 7. Patients with hypertension who cannot obtain good control through single hypotensive therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Having a history of unstable angina; New diagnosis of angina within 3 months prior to screening or myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF) require long-term use of antiarrhythmic drugs and New York heart association grade II or greater; 8. A long unhealed wound or incomplete fracture; 9. A history of organ transplantation; 10. Imaging studies have shown that the tumor has invaded important blood vessels or that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal hemorrhage; 11. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency (14 days before randomization must be met: INR is within the normal range without anticoagulants). Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; International standardization in prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 12. Screening move/vein thrombosis incidents happened in the year before, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (line by chemotherapy venipuncture vein thrombosis by researchers have judgment recovered except) and pulmonary embolism, etc; 13. Having a history of psychotropic substance abuse and cannot be cured or having a mental disorder; 14. A history of immunodeficiency, other acquired, congenital immunodeficiency disorders, or a history of organ transplantation; 15. According to the judgment of the researchers, there is serious harm to the patient's safety or the accompanying diseases that affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;adverse event; | — |
Countries
China
Contacts
Public ContactJing Liang
The First Affiliated Hospital of Shandong First Medical University
Outcome results
None listed