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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 |
|---|---|---|---|
| apatinib XELOX and radiotherapy | Experimental | apatinib:250mg qd po XELOX:Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) |
|
| XELOX and radiotherapy | Active Comparator | XELOX:Capecitabine 1000mg/m2 bid d1-14,Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy:45Gy/25f (1.8Gy/f/d,5 f/w) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | apatinib:250mg qd po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The pathological complete response rate(pCR) | The lesion disappeared completely by pathology | within 3 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Baseline to measured stable disease | within 3 weeks after surgery |
| R0-resection rate | There was no residual by the microscope |
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Inclusion Criteria:
Age:18 to 70 years old (man or female);
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;
Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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;
Life expectancy greater than or equal to 6 months;
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;
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qun Zhao | Contact | 13930162111 | Zhaoqun516@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qun Zhao | Hebei Medical University Fourth Hospital | Principal Investigator |
| Jun Wang | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34540013 | Derived | Guo H, Li Y, Lin C, Cheng Y, Zhang Z, Wang D, Zhao X, Liu Y, Jing S, Yang P, Tian Y, Liu Y, Wang J, Zhao Q. Efficacy and safety of neoadjuvant chemoradiotherapy plus apatinib for patients with locally advanced, HER2-negative, Siewert's type II-III adenocarcinoma of esophagogastric junction: a single-arm, open-label, phase II trial. Am J Transl Res. 2021 Aug 15;13(8):9015-9023. eCollection 2021. |
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| Capecitabine |
| Drug |
1000mg/m2 bid d1-14 |
|
| Oxaliplatin | Drug | 130 mg/m2 Ivgtt d1 q3w |
|
| Radiotherapy | Radiation | 45Gy/25f (1.8Gy/f/d,5 f/w) |
|
| within 3 weeks after surgery |
| Disease-free survival(DFS) | Baseline to measured date of recurrence or death from any cause | 3 year |
| Overall survival (OS) | Baseline to measured date of death from any cause | 3years |
| Adverse events | 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. | 3 year |
| ID | Term |
|---|---|
| C553458 | apatinib |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
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