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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(apatinib Xelox) | Experimental | Preoperative: apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) Postoperative: Capecitabine 1000mg/m2 bid d1-14 q3w 2 cycles |
|
| B(Xelox) | Active Comparator | Preoperative: Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) Postoperative: Capecitabine 1000mg/m2 bid d1-14 q3w 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib Capecitabine Oxaliplatin | Drug | apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pathological complete response rate(pCR) | The lesion disappeared completely by pathology | [ Time Frame: within 3 weeks after surgery ] |
| Disease-free survival(DFS) | Baseline to measured date of recurrence or death from any cause | [ Time Frame: 3 year ] |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Baseline to measured stable disease | [ Time Frame: Preoperative ] |
| Disease Control Rate(DCR) | Baseline to measured disease progression |
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Inclusion Criteria:
(1) Baseline blood indicators meet the following criteria:HB≥80g/L;ANC≥1.5×109/L;PLT≥90×109/L;WBC≥4.0×109/L and ≤15×109/L (2) Baseline biochemical indicators meet the following criteria: ALT and AST≤2.5ULN, but<≤5ULN if the transferanse elevation is due to liver metastases; ALP≤2.5ULN;TBiL≤1.5ULN;Cr≤1.5ULN,Endogenous creatinine clearance rate ˃60 ml/min (Cockcroft-Gault formula);APTT≤1.5ULN,and INR or PT≤1.5ULN.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QunZhao | Recruiting | Shijiazhuang | Hebei | China |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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| Capecitabine Oxaliplatin | Drug | Preoperative: Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w |
|
| [ Time Frame: Preoperative ] |
| R0-resection rate | There was no residual by the microscope | [ Time Frame: within 3 weeks after surgery ] |
| Overall survival (OS) | Baseline to measured date of death from any cause | [ Time Frame: 3years ] |