gastric cancer
Conditions
Interventions
Case series:apatinib mesylate combined with paclitaxel
Sponsors
Jiangxi Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years old or above, male or female; 2. Histopathologically confirmed advanced gastric cancer has extramural evaluable lesions (spiral CT scanning is greater than 10mm, meeting the RECIST 1.1 standard); 3. Locally advanced, recurrent or metastatic gastric cancer that cannot be operated on; 4. The first-line chemotherapy (oxaliplatin/cisplatin/irinotecan combined fluorouracil, 2 weeks or 3 weeks) with at least 2 cycles has been completed, and the efficacy evaluation is PD; Patients who have not been treated with egfr-tki for more than two weeks; 5. ECOG PS: 0-1 points; 6. Baseline blood routine and biochemical indicators meet the following criteria: hemoglobin or 80 g/L; neutrophil count (ANC) absolutely acuity 1.5 x 10^9/L; platelet p 90x10^9/L; ALT, AST acuities were 2.5 times the normal ceiling; A normal upper limit of less than or equal to 5 times; serum total bilirubin acuities were 1.5 times the normal ceiling; serum creatinine acuities were 1.5 times the normal ceiling; serum albumin acuity 30 g/L; 7. The expected survival period is greater than or equal to 3 months; 8. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception. In the case of men, surgical sterilization should be carried out or appropriate methods of contraception should be agreed to during the trial and 8 weeks after the last administration of the experimental drugs; 9. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Those who have proved allergic to apatinib and/or its excipients; 2. People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-i above coronary heart disease, arrhythmia in class I (including QTc lengthened men > 450 ms, women > 470 ms) and the grade I cardiac insufficiency; Patients with urinary protein positive; 3. Various factors (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) that affect oral drugs; 4. Patients with a definite tendency to bleeding in the gastrointestinal tract include the following situations: local active ulcer lesions, and fecal occult blood (++) cannot be included in the group; Having a history of black stool and hematemesis within 2 months; For stool occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as cancer of the stomach ulcer type, and the main researchers think that the person may be the digestive tract hemorrhage; 5. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 6. Patients with central nervous system metastasis; 7. Women who are pregnant or breastfeeding; 8. Patients with other malignant tumors within 5 years; 9. Patients with a history of psychotropic substance abuse who cannot be cured or who have mental disorders; 10. Patients who have participated in clinical trials of other drugs within 4 weeks; 11. Those who have received VEGFR inhibitors, such as sorafenib and sunitinib therapy; 12. According to the judgment of researchers, patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 13. The researchers considered the inclusion inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactRongfeng Song
Jiangxi Tumor Hospital
Outcome results
None listed