Gastric Cancer
Conditions
Interventions
A:Tegrio, twice daily, orally after breakfast and dinner, d1-14, q3w
apatinib, 250mg, po, qd, q3w
B:Oxaliplatin 130 mg/m2, ivdrip,d1,q3w
tegrio, twice daily, orally after breakfast and dinner, d1-14, q3w
Sponsors
National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20~80 years; 2. ECOG PS of 0-1; 3. Pts had radical (D2R0) gastrectomy (No less than 16 lymph nodes were detected); 4. Histologically proven gastric cancer of stage parts of IIIA (T4aN2M0T3N2M0T2N3aM0), IIIB and IIIBC (8th AJCC TNM). 5. Major organ function has to meet the following standards: 1) WBC=3500/ mm3; 2) Hb= 9.0 g/dL; 3) ANC=1,500/mm3; 4) PLT=100,000/mm3 5) TBil=1.5 ULN; 6) ALT/AST=2.5 ULN; 7) INR=1.5; 8) Cr=1.5 ULN; 6. The ECG was normal in the first 4 weeks, and there was no obvious clinical symptoms of heart disease; 7. Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with poor-controlled arterial hypertension; 2. Inability to swallow, Complete or incomplete gastrointestinal obstruction, Active gastrointestinal bleeding and gastric perforation; 3. History of bradycardia or prolonged QT interval; 4. Postoperative digestive tract fistula, wound dehiscence; 5. Known allergy to tegrio or apatinib, or metabolic disorders 6. Received chemotherapy, radiotherapy or targeted therapy before surgery; 7. Other experimental drugs are being used or in other clinical trials; 8. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases;The heart disease with apparent clinical symptom, be like: congestive heart failure, the coronary heart disease with apparent symptom, the heart rhythm that medicaments controls hard, hypertension, or inside 6 months ever had myocardial infarction to attack, or heart function is incomplete person; 9. The patient has peripheral nervous system disorder or obvious mental disorder and central nervous system disorder; 10. >CTC AE 2 Clinical severe infection; 11. Patients with other cancers other than gastric cancer within 5 years of the start of treatment in this study, except cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis]; 12. A history of organ transplantation (including bone-marrow autologous transplantation and peripheral stem cell transplantation); Patients who have been treated with systemic steroids for a long time (note: short-term users can be selected if they stop taking > for 2 weeks); 13. Pregnant women, lactating women, women of child-bearing age and their spouses refuse to take effective contraceptive methods; 14. No capacity for legal transactions, medical or ethical reasons affecting the continuation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years disease free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactYan Song
National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed