Gastroesophageal Junction Adenocarcinoma
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.
Interventions
DRUGOxaliplatin
130 mg/m2 Ivgtt d1 q3w
RADIATIONRadiotherapy
45Gy/25f （1.8Gy/f/d，5 f/w）
DRUGapatinib
apatinib：250mg qd po
DRUGCapecitabine
1000mg/m2 bid d1-14
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18 to 70 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≥1.5×109/L; PLT≥90×109/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
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 ,classⅢ-Ⅳcardiac 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 | Description |
|---|---|---|
| The pathological complete response rate(pCR) | within 3 weeks after surgery | The lesion disappeared completely by pathology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | within 3 weeks after surgery | Baseline to measured stable disease |
| R0-resection rate | within 3 weeks after surgery | There was no residual by the microscope |
| Disease-free survival(DFS) | 3 year | Baseline to measured date of recurrence or death from any cause |
| Overall survival (OS) | 3years | Baseline to measured date of death from any cause |
| Adverse events | 3 year | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit. |
Countries
China
Contacts
Primary ContactQun Zhao
Outcome results
None listed