the clinical research of mesylate apatinib combined with docetaxel and s-1 as the first-line treatment of metastatic gastric cancer

Conditions: Metastatic Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of apatinib mesylate tablets combined with docetaxel and s-1 as the first-line treatment of metastatic gastric cancer.


Eligibility criteria:
inclusion criteria: 1. age: 18-70 years of age; 2. recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction diagnosed by pathology (including histology or cytology); 3. 1 measurable lesions at least should be detected by ct/mri examination in accordance with the recist(response evaluation criteria in solid tumors）1.1; 4. had not received other anti vegfr targeted therapy; 5. ecog（eastern cooperative oncology group）ps（performance status）:0-2 scores; 6. the expected survival time is more than 3 months; 7. if patient had accepted the chemotherapy, the time from the last chemotherapy should be more than 6 months; 8. the damage caused by other treatments has been restored, and the subjects received radiotherapy or surgery over 4 weeks ago, and the wound has healed completely; 9. the main organ function is normal, which should meet the following criteria: (1) blood routine examination standards should be met: (no blood transfusion within 14 days) a. hb（hemoglobin） = 90g/l, b. anc(absolute neutrophil count) = 1.5 \* 109/l, c. plt（platelet） = 80 \* 109/l; (2) biochemical examination shall comply with the following criteria: a. bil（bilirubin） \ 50ml/min (cockcroft-gault formula); 10. women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test; 11. participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up. exclusion criteria: 1. suffering from other malignant tumors previously or at the same time, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ; 2. patients have used the paclitaxel class and / or s-1 as the adjuvant therapy in 2; 3. have been confirmed to be allergic to docetaxel, 5-fluorouracil, apatinib and / or its accessories; 4. the blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure \>140 mmhg, diastolic pressure \>90 mmhg); 5. patients are suffering from severe cardiovascular disease: the ii level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including qtc(corrected qt interval) prolongation of male \> 450 ms, of female \> 470ms ); and patients have iii-iv grade of cardiac insufficiency, or left ventricular (lvef) \< 50% shown by echocardiography according to the nyha(new york heart association) standard; 6. patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative \>1.0g); 7. have a variety of factors that affect oral drugs (such as difficulty in swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 8. patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage; 9. coagulation dysfunction (inr(international normalized ratio)\>1.5, aptt(activated partial thromboplastin time)\>1.5 uln), with bleeding tendency; 10. patients with a history of psychotropic substance abuse and unable to give up or have mental disorders; 11. patients who participated in other clinical trials within 4 weeks; 12. have received the vegfr inhibitors, such as sorafenib and sunitinib; 13. according to the researcher's judgment, there are other accompanying disease endangering the patient's safety or affect the patient to complete the study. 14. patients with central nervous system metastasis; 15. pregnant or lactating women; 16. the researchers consider those who were not suitable for inclusion.

Keywords: mesylate apatinib the first-line treatment metastatic gastric cancer