NCT03986385Unknown3 期
Prospective, Randomized, Controlled, Multicenter, Phase III Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Disease-free survival(DFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 to 70 years old) at the time of voluntarily signing informed consent;
- •Histologically or cytologically confirmed adenocarcinoma. The her-2 negative was detected by immunohistochemistry or fluorescence in situ hybridization;
- •Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy;
- •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;
- •Life expectancy greater than or equal to 6 months;
- •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≥1.5×109/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.
排除标准
- •Allergic to apatinib, capecitabine and oxaliplatin;
- •The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
- •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;
- •A variety of factors influencing oral drugs (such as unable to swallow, nausea,vomiting,chronic diarrhea and intestinal obstruction, etc);
- •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;
- •Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
- •Pregnant or lactating women;
- •Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •Less than 4 weeks from the last clinical trial;
- •The researchers think inappropriate.
研究组 & 干预措施
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
干预措施: Apatinib Capecitabine Oxaliplatin (Drug)
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
干预措施: Capecitabine Oxaliplatin (Drug)
结局指标
主要结局
Disease-free survival(DFS)
时间窗: [ Time Frame: 3 year ]
Baseline to measured date of recurrence or death from any cause
The pathological complete response rate(pCR)
时间窗: [ Time Frame: within 3 weeks after surgery ]
The lesion disappeared completely by pathology
次要结局
- R0-resection rate([ Time Frame: within 3 weeks after surgery ])
- Objective response rate (ORR)([ Time Frame: Preoperative ])
- Overall survival (OS)([ Time Frame: 3years ])
- Disease Control Rate（DCR）([ Time Frame: Preoperative ])
研究者
Qun Zhao
Surgical director
Hebei Medical University
研究点 (1)
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