locally advanced gastric cancer
Conditions
Interventions
systemic venous chemotherapy group:(m)Folfox6 chemo-regimen, repeated every 2 week
intra-arterial chemotherapy group:(m)Folfox6 chemo-regimen, repeated every 2 week
Sponsors
Xijing Hospital of Digestive Diseases. The Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. The clinical evaluation: locally advanced gastric cancer(level 3 or 4 lymph node highly suspicious on imagineg or confirmed by biospy, invasion or encasement of major vascular structures, without diastant metastasis or retroperitoneal lymphadenectasis); 3. endoscopic biopsy diagnosis of gastric adenocarcinoma; 4. without history of gastroenteric tumor; 5. without jaundice or digestive tract obstruction; 6. without severe cardiorespiratory dysfunction; 7. without acute infection; 8. coagulation is normal; 9. life expectancy> 6 months; 10. Karnofsky score >=70; 11. Laboratory parameters: WBC>=4*10^9/L; PLT>=80*10^9/L; HB>=90g/L; STB=60 ml/min (Cockcroft-Gault); 12. Voluntary to participate and sign informed consent document; 13. Female have to contracept during treatment; 14. The patients did not receive any palliative chemotherapy or molecular targeted drugs for locally advanced gastric cancer treatment.
Exclusion criteria
Exclusion criteria: 1. The progress of the disease is fast; 2. patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation; 3. Have participated in other similarclinical trial within the latest 2 months; 4. pregnancy, breast-feeding women; 5. with severe infection that requires intravenous use of antibiotics, anti-fungal or anti-virus therapy; 6. Refuse to comply with the chemotherapy regimen and follow up; 7. Refuse to sign the consent document; 8. With severe allergic history or allergy with chemotherapy drugs; 9. had long received systemic steroid treatment (Note: short-term users of withdrawal> 2 weeks can be selected); 10. Have the malignant tumor of other tissue within 5 years(excluding cerical cancer, basal cell carcinoma or squamous carcinoma); 11. Serious coagulation abnormality and hemorrhagic tendency; 12. The patients with mental disease have the poor compliance; 13. With severe cardiaovascular diseases including uncontrolled hypertension, unstable angina pectoris, cardiac infarction, heart failure (>2 according to NYHA standard) and severe cardiac arrhythmia; 14. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes; 15. Other patients that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate;overall survial time;Surgical resection rate;Partial Response;Complete Response;5-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse event; | — |
Countries
China
Contacts
Public ContactQingchuan Zhao
Outcome results
None listed