NCT03320629终止2 期
A Prospective Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.
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
- •Age:18 to 70 years old (man or female);
- •Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence );
- •The distant metastatic is oligotransfera, with radiotherapy indication;
- •Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Major organ function has to meet the following certeria:
- •For results of blood routine test (without blood transfusion within 14 days)
- •ANC≥3.0×109/L;
- •PLT≥100×109/L;
- •For results of blood biochemical test：
- •TBIL<1.5×ULN；
- •ALT and AST<2.5×ULN, but< 5×ULN if the transferanse elevation is due to liver metastases；
- •Serum creatinine ≤1ULN , calculated creatinine clearance>50 ml/min(per the Cockcroft-Gault formula);
- •Life expectancy greater than or equal to 3 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;
- •Coagulation function is normal, without active hemorrhage and thrombosis:
- •INR<1.5×ULN
- •APTT<1.5×ULN
- •Participants were willing to join in this study, and written informed consent;
- •Participants were good adherence, cooperate with the follow-up.
排除标准
- •Allergic to apatinib;
- •Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease and arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac 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;
- •Active ulcerative lesions, and defecate occult blood (+ +);
- •Has melena and hematemesis in three months;
- •For defecate occult blood (+) or(+/-) ,must be received gastroscopy, the physicians consider there are potential bleeding risk with ulcers, hemorrhagic diseases;
- •Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
- •Patients with thrombosis or anticoagulant drug therapy;
- •Patients with symptoms of central nervous system metastasis; Patients with other malignant tumors within 5 years (except for the treated 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;
- •Have received prior treatment with anti- VEGF/VEGFR;
- •Researchers considered there are serious harm to patient safety or affect the patients who have completed the study;
- •Pregnant or lactating women;
- •The researchers think inappropriate.
研究组 & 干预措施
apatinib and S-1 radiotherapy
Experimental
apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: apatinib S-1 radiotherapy (Combination Product)
S-1 radiotherapy
Active Comparator
S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: S-1 radiotherapy (Combination Product)
结局指标
主要结局
Progression free survival
时间窗: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
次要结局
- Disease control rate(tumor assessment every 6 weeks ，up to 24 month)
- Objective response rate(tumor assessment every 6 weeks，up to 24 months)
- Overall survival(the first day of treatment to death or last survival confirm date，up to 24 months)
- Side effects(evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0)
研究者
Jun wang
Director of radiotherapy department1
Hebei Medical University Fourth Hospital
研究点 (1)
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