Advanced Gastric Cancer
Conditions
Interventions
one:First-line treatment
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 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 RECIST1.1; 4. had not received other anti VEGFR targeted therapy; 5. ECOG PS: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) HB 90g/L, ANC 1.5*10^9/L, PLT 80*10^9/L; (2) biochemical examination shall comply with the following criteria: BIL 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
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 prolongation of male > 450 ms, of female > 470ms); and patients have III-IV grade of cardiac insufficiency, or left ventricular (LVEF) 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>1.5, APTT>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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival time;Objective Response Rate;disease control rate;quality of life;drug adverse reaction; | — |
Countries
China
Contacts
Public ContactZhou Fuxiang
Zhongnan Hospital of Wuhan University
Outcome results
None listed