Gastric adenocarcinoma
Conditions
Interventions
1:Trastuzumab plus XELOX protocol
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 70 years; 2. Patients with unresectable advanced or metastatic gastric adenocarcinoma which are HER2 IHC2 + / FISH-positive or IHC3 + according to the updated HER2 Test Guideline for Chinese Gastric Cancer(2016 version), as well as patients with postoperative recurrence; 3. The functional status of the ECOG (Eastern Co-operative Oncology Group) is 0-2; 4. Not received targeted therapy, radiotherapy and biological therapy; 5. Baseline blood and biochemical parameters meet the following standards: neutrophil count =1.5×10^9/L; hemoglobin = 80 g/L; platelet count = 100×10^9/L; total bilirubin = 1.5×ULN; ALT , AST = 2.5×ULN; 6. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment, and the result is negative; 7. Patients voluntarily join the study, sign informed consent forms and coordinate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to adjuvant chemotherapeutic agents capecitabine and oxaliplatin, and to the targeted therapeutic drug trastuzumab; 2. Patients with hypertension and who are unable to fall within the normal range with antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), patients with grade I or more CHD, grade I arrhythmias (including QTc prolongation Male> 450 ms, female> 470 ms) and grade I cardiac insufficiency; patients with positive urine protein; 3. With a variety of factors that affect oral drugs (unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with a clear tendency to gastrointestinal bleeding, including the following: patients with a local active ulcer lesions and fecal occult blood (++); patients with a history of melena and hematemesis within 2 months; patients with fecal occult blood (+) and primary tumor of the stomach tumor without surgical resection, endoscopy should be required, patients with ulcerative gastric cancer and patients who may occur gastrointestinal bleeding; 5. Coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), with a tendency to bleed; 6. Patients with central nervous system metastasis; 7. Patients with other malignancies within 5 years (excluding the patients whose skin basal cell carcinoma and cervix carcinoma have been cured); 8. Patients with a history of psychoactive substance abuse who are unable to quit or have a mental disorder; 9. Patients with acute infection and antibiotic therapy are required; 10. Patients who have participated in clinical trials of other drugs within four weeks; 11. According to the investigator's judgment, patients with concomitant diseases which are seriously harmful to the patient's safety or affect the patient to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PR;OS; | — |
Countries
China
Contacts
Public ContactFu Guo-hui
Shanghai General Hospital
Outcome results
None listed