Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring Advanced gastric cancer apatinib Maintenance therapy Read More

Inclusion Criteria:

1. age: more than 18 years old, male or female;
2. histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma, stomach with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST standard 1.1);
3. inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or esophagogastric junction;
4. first-line chemotherapy (oxaliplatin / cisplatin / paclitaxel combined with fluorouracil / either drug, docetaxel or S-1 / capecitabine), efficacy evaluation of SD or CR or PR may, from the last chemotherapy cycle time is not more than 28 days;
5. when evaluating the maximum response rate of chemotherapy (chemotherapy is not less than 4 cycles), enter maintenance therapy. (maximum response rate: compared with the previous curative effect evaluation, the target lesion no longer continued to shrink);
6. ECOG PS:0-1 points;

7. baseline blood routine and biochemical parameters met the following criteria: Hemoglobin is larger than 80g/L,

   • the absolute neutrophil count (ANC) = 1.5 * 109/L, Over 90 * 109/L platelets,
   • ALT, AST less than 2.5 times the upper limit of normal value, Equal to or less than 5 times the upper limit of normal (liver metastasis),
   • the serum total bilirubin is less than 1.5 times the upper limit of normal value, Serum creatinine. Less than 1.5 times the upper limit of normal value, Serum albumin is more than 30g/L;
8. more than the expected survival time in March;
9. women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to take the appropriate method of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial;
10. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.

Exclusion Criteria:

1. confirmed of apatinib and / or its accessories allergy;
2. with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (>140 systolic blood pressure mmHg, diastolic blood pressure >90 mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc prolongation > 450 male MS, female MS > 470) and grade I heart function insufficiency; patients with positive urinary protein;
3. , there are a variety of factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); The 4. has a clear tendency in patients with gastrointestinal bleeding, including the following: local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2 months melena, hematemesis history; for fecal occult blood (+) and gastric primary tumor without surgical resection. And for gastroscopy, such as gastric cancer, and researchers believe that may occur in massive hemorrhage of digestive tract were;

5. coagulation dysfunction (INR>1.5, APTT>1.5, ULN), with bleeding tendency; 6. patients with central nervous system metastasis; 7. pregnant or lactating women; A patient with other malignancies within 8.5 years; 9. patients who have history of psychotropic substance abuse and are unable to quit or have mental disorders; Patients who participated in other clinical trials within 10.4 weeks; 11. received VEGFR inhibitors, such as Sola Fini and sunitinib therapy; 12. according to the researcher's judgment, there are patients who seriously endanger the safety of patients or affect the patients who complete the study; 13., the researchers considered unsuitable for inclusion.