Gastric cancer
Conditions
Interventions
experimental group:apatinib combined with S-1 and oxaliplatin
control group: S-1 and oxaliplatin
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Gastric adenocarcinoma confirmed by pathology (including histology or cytology) meets one of the following conditions: Class I, Class II, Class III and a very small number of Class IV gastric adenocarcinoma classified according to biological behavior (see Appendix 1 for details); N3; widespread or other organ metastasis; Fusion and mass lymph node metastasis, Kukerburg tumors, etc. 3. CT/MRI and PET-CT and laparoscopic examination are needed to ascertain the above stages for the diagnosis of gastric cancer before operation. 4. Initial patients without radiotherapy, chemotherapy, targeted therapy or immunotherapy in the past; 5. ECOG PS: 0-2; 6. The estimated survival time is more than 3 months. 7. The main organs function normally and meet the following criteria: (1) Blood routine examination standards should be met: (no blood transfusion within 14 days): A. HB (> 100g/L); B. WBC (> 3*10^9/L); C. ANC (>1.5*10^9/L); D. PLT (> 100*109/L). (2) Biochemical tests should meet the following criteria: A. BIL 60 ml/min (Cockcroft-Gault formula). 8. Pregnancy test (serum) must be carried out within 7 days before admission for women of childbearing age, and the results are as follows: Negative and willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the drug; for men, surgical sterilization or consent to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the drug; 9. No other clinical studies were conducted before and during the treatment. 10. Subjects volunteered to join the study and signed informed consent. They had good compliance and cooperated with each other.
Exclusion criteria
Exclusion criteria: 1. History of previous upper abdominal surgery (excluding laparoscopic cholecystectomy); 2. Her-2 positive patients who are willing to receive Herceptin treatment (if the gene target is unknown, patients may benefit from the judgement of the researchers can be included in the study); 3. Patients with surgical treatment and chemotherapy contraindications or physical condition and organ function are not allowed to undergo large abdominal surgery; 4. Distant metastasis to brain and bone; 5. Complicated with serious heart, liver and kidney diseases; neurological and psychiatric diseases; with severe infections; jaundice and digestive tract obstruction. 6. Pregnant or lactating women; 7. The patients with hypertension whose systolic blood pressure is > 140 mmHg and diastolic blood pressure is > 90 mmHg can not be reduced to normal range by antihypertensive drugs. 8. Patients with grade I or above coronary heart disease, arrhythmia (including prolonged QTc interval > 450 ms for males and 470 MS for females) and cardiac insufficiency; 9. Patients with definite tendency of gastrointestinal bleeding include local active ulcer, occult blood in stool (++) and history of melena or hematemesis within 2 months; patients with abnormal coagulation function (INR > 1.5, APTT > 1.5 ULN); 10. Patients who have a history of cardiovascular and cerebrovascular diseases are still taking thrombolytic or anticoagulant drugs orally. 11. Urinary protein positive patients (urinary protein detection 2 + or more, or 24-hour urinary protein quantification > 1.0g); 12. There are many factors affecting oral medicines (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.). 13. Anaphylactic reactions to the drugs used; 14. Long-term use of other medicines (including Chinese herbal medicines) before and after admission can not ensure that the study is conducted in accordance with the requirements; 15. According to the judgement of the researchers, there are other patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study. 16. Researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radical resection rate after transformation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| excision rate after transformation therapy;ORR;pathCR+pathPR;surgical safety;medicine safety; | — |
Countries
China
Contacts
Public ContactChen Luchuan
Fujian Cancer Hospital
Outcome results
None listed