gastric cancer
Conditions
Interventions
combined Apatinib
chemotherapy group only:combined chemotherapy
Sponsors
The People's Liberation Army 101 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. man or woman aged 18 years old and older; 2. Have radical resection of gastric cancer, more than D2; 3. Postoperative stage T3, T4 or N + (positive) in patients with gastric cancer; 4. ECOG score: 0-1; 5. The main organ function, that meet the following criteria:HB>=80 g/L; ANC>=1.5*10^9/L; PLT>=90*10^9/L; ALT and AST =30g/L; 6. no distant metastasis; 7. full of marrow, liver and kidney function, heart function; 8. The expected survival more than three months; 9. experiment and during the last eight weeks after administration of the test drugs using appropriate methods contraception. For men shall be agreed to during the trial and after the last administration of the test drugs eight weeks using appropriate methods of contraception or sterilization surgery; 10. The subjects voluntarily joined the study, informed consent, good compliance, with the follow-up.
Exclusion criteria
Exclusion criteria: 1. patients who are allergic to lapatinib or any of the ingredients in lapatinib tablets; 2. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) above the level of suffering I coronary heart disease or arrhythmia (including QT interval of men>450 ms,women>470ms) and Class I cardiac insufficiency; urinary protein positive patients; 3. obvious factors of oral drug absorption, such as inability to swallow, nausea, emesis,chronic diarrhea and intestinal obstruction; 4. Patients with clear gastrointestinal bleeding concerns, including the following situations: local active ulcerative lesions, and defecate occult blood (++); black, hematemesis history within 2 months; for stool occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy; such as ulcer type of gastric cancer, the digestive tract hemorrhage may occur; 5. coagulation abnormalities (INR> 1.5 or APTT>1.5ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency; 6. Accompanied by the central nervous system transfer; 7. pregnant or lactating; 8. before accepting any targeted therapy; 9. postoperative pathology in cut edge positive patients; 10. performer D0, D1 resection; 11. have medical systemic disease and psychiatric diseases are not suitable for radiation and chemotherapy; 12. with acute infection requires antibiotic treatment; 13. patients participated in other drug clinical trials within four weeks; 14. serious to endanger the safety of patients or influence patients completed the research associated with disease; 15. patients who physicians suggest not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactWu Guozhong
The People's Liberation Army 101 Hospital
Outcome results
None listed