gastric cancer
Conditions
Interventions
Case series:Apatinib+SOX(biweekly)
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form; 2. Aged 18 to 70 years old; 3. Pathologically confirmed advanced stomach or gastroesophageal junction adenocarcinoma, having at least one measurable lesion (CT scan> 10 mm, according to the RECIST 1.1 criteria; localized mass at the gastroesophageal junction is classified as "immeasurable"; 4. Patients with unresectable,recurrent or metastatic stomach or gastro esophageal junction cancer; 5. No systematic chemotherapy regimen has been used before(adjuvant/neoadjuvant chemotherapy for recurrence within 6 months after the end of adjuvant/neoadjuvant chemotherapy, adjuvant/neoadjuvant chemotherapy is defined as first-line treatment); 6. Previous radiotherapy must be completed at least 4 weeks before enrolling, and the acute toxic must be recovered; 7. ECOG(Eastern Cooperative Oncology Group) 0~2; 8. The Expected lifetime = 3 months; 9. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function ). For example: hemoglobin (> 8.0 g/dL) (no blood transfusion and blood products within 14 days, no G-CSF or other hematopoietic stimulating factors corrected); absolute neutrophil count (> 1.5*10^9/L); white blood cells (WBC) > 3 * 10^9/L; platelet count (> 100 * 10^9/L); total bilirubin (< 1.5 * normal value upper limit (ULN); AST (SGOT) / ALT (SGPT) (< 2.5 * normal value upper limit), unless there is a liver metastasis. When liver metastases occur, the above value must be less than 5*ULN; serum creatinine is less than 1.5 *ULN; 10. Patients will take contraceptive measures for the duration of the treatments and 8 weeks after the last treatment.
Exclusion criteria
Exclusion criteria: 1. Involving in other clinical study at the same time; 2. Patients with active brain metastasis, malignant meningitis and spinal cord compression (who had completed treatment 21 days before enrollment and had stable symptoms of brain metastasis can be enrolled in the group, but no symptoms of cerebral hemorrhage should be confirmed by MRI, CT or venography); 3. Previous or concurrent cases of other untreated malignancies, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; 4. The following several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 5. Taking the test drugs within 14 days before enrolling; 6. Patients with uncontrol hypertension in the use of two antihypertensive drugs (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg);Patients with severe cardiovascular disease: Patients with grade II myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval =470 ms); According to NYHA standard , patients with grade III ~?cardiac insufficiencyleft ventricular ejection fraction (LVEF) under 50% confirmed by echocardiography; 7. Positive urinary protein(uric albumen check(++),or Twenty-four hours urinary protein content>1.0g); 8. Patients with coagulation dysfunction (INR>1.5, APTT>1.5 UNL) or bleeding tendency; 9. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month before enrolling; 10. Patients having undergone major surgery or having been selected for severe traumatic injuries, fractures or ulcers within two weeks of the start of the study should be cured from any impact of major surgery; 11. Patients with severe, uncontrollable diseases, non-metastatic systemic diseases, or active, uncontrollable infections are considered to be at greater medical risk. Including uncontrolled ventricular arrhythmias, recent (3 months) myocardial infarction, uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome, HRCT suggesting widespread bilateral interstitial lung disease or any psychiatric disorder that may impede informed consent; 12. Patients with immunodeficiency,for example, serological tests suggest that human immunodeficiency virus (HIV) is positive; 13. Patients with allgetic reaction to apatinib, teggio or oxaliplatin or its components; 14. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;QoL; | — |
Countries
China
Contacts
Public ContactHaiping Jiang
The First Affiliated Hospital Zhejiang University
Outcome results
None listed