adenocarcinoma at gastroesophageal junction
Conditions
Interventions
Experimental:Apatinib+chemoradiotherapy
control:chemoradiotherapy
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years old (man or female); 2. Confirmed to Siewert II, III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter =8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry; 3. Patients with Stage for III by CT/MRI (According to the eighth edition of AJCC); 4. Patients with measurable lesions(measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. Major organ function has to meet the following certeria: HB=80g/L; ANC=1.5×10^9/L; PLT=90×10^9/L; ALT and AST=2.5 ULN, but<=5 ULN if the transferanse elevation is due to liver metastases TBIL<1.5 ULN Serum creatinine =1.5 ULN; 7. Life expectancy greater than or equal to 6 months; 8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 9. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergic to apatinib, capecitabine and oxaliplatin; 2. The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive; 3. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,class?-?cardiac insufficiency; 4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; 6. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 7. Pregnant or lactating women; 8. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ); 9. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10. Less than 4 weeks from the last clinical trial; 11. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR?; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;R0-resection rate;3 DFS;3 OS;safety; | — |
Countries
China
Contacts
Public ContactQun Zhao
Fourth Hospital of Hebei Medical University
Outcome results
None listed