gastroesophageal junction adenocarcinoma
Conditions
Interventions
experimental group:Preoperative: Apatinib 250mg q.d. p.o. q4w
XELOX: Capecitabine 1000mg/m2 b.i.d. d1-14, Oxaliplatin 130 mg/m2 i.v.gtt. d1 q3w
Radiotherapy 45Gy/25f (1.8Gy/f/d, 5 f/w) Postoperative: Capecitabine 1000mg/m2 b.i.d. d1-14 q3w 2 cycles.
Active Comparator:Preoperative: XELOX: Capecitabine 1000mg/m2 b.i.d. d1-14, Oxaliplatin 130 mg/m2 i.v.gtt. d1 q3w, Radiotherapy: 45Gy/25f (1.8Gy/f/d,5 f/w)
Postoperative: Capecitabine 1000mg/m2 b.i.d. d1-14 q3w 6 cycles.
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 to 70 years old) at the time of voluntarily signing informed consent; 2. Histologically or cytologically confirmed adenocarcinoma. The her-2 negative was detected by immunohistochemistry or fluorescence in situ hybridization; 3. Confirmed to Siewert II, III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter =10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Life expectancy greater than or equal to 6 months; 8. Subject must meet all of the following criteria based on the laboratory tests within 14 days prior to the first dose of study treatment. (1) Baseline blood indicators meet the following criteria: HB>=80g/L; ANC>=1.5x10^9/L; PLT>=90x10^9/L; WBC>=4.0x10^9/L and = 60 ml/min (Cockcroft-Gault formula); APTT<=1.5xULNand INR or PT<=1.5xULN; 9. 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; 10. 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 III-IV 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 |
|---|---|
| The pathological complete response rate (pCR);Disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease Control Rate (DCR);R0-resection rate;Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactQun Zhao
Fourth Hospital of Hebei Medical University
Outcome results
None listed