NCT03154983Unknown2 期
The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer
Zhou Fuxiang1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- progress-free survival time
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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: 18-70 years of age;
- •recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction diagnosed by pathology (including histology or cytology);
- •1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;
- •had not received other anti VEGFR targeted therapy;
- •ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-2 scores;
- •the expected survival time is more than 3 months;
- •if patient had accepted the chemotherapy, the time from the last chemotherapy should be more than 6 months;
- •the damage caused by other treatments has been restored, and the subjects received radiotherapy or surgery over 4 weeks ago, and the wound has healed completely;
- •the main organ function is normal, which should meet the following criteria: (1) blood routine examination standards should be met: (no blood transfusion within 14 days) A. HB（hemoglobin） = 90g/L, B. ANC(absolute neutrophil count) = 1.5 * 109/L, C. PLT（platelet） = 80 * 109/L; (2) biochemical examination shall comply with the following criteria: A. BIL（bilirubin） <1.25 normal upper limit (ULN), B. ALT（glutamic-pyruvic transaminase） and AST（glutamic-oxalacetic transaminase）<2.5ULN（upper limit of normal）, if subjects have liver metastases, the ALT and AST <5ULN（upper limit of normal）, C. Cr ≤ 1ULN, CCR（creatinine clearance rate） > 50ml/min (Cockcroft-Gault formula);
- •women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test;
- •participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.
排除标准
- •Suffering from other malignant tumors previously or at the same time, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ;
- •Patients have used the paclitaxel class and / or S-1 as the adjuvant therapy in 2;
- •have been confirmed to be allergic to docetaxel, 5-fluorouracil, apatinib and / or its accessories;
- •the blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90 mmHg);
- •patients are suffering from severe cardiovascular disease: the II level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc(corrected QT interval) prolongation of male > 450 ms, of female > 470ms ); and patients have III-IV grade of cardiac insufficiency, or left ventricular (LVEF) < 50% shown by echocardiography according to the NYHA(New York Heart Association) standard;
- •patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative >1.0g);
- •have a variety of factors that affect oral drugs (such as difficulty in swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
- •patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage;
- •coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin time)>1.5 ULN), with bleeding tendency;
- •patients with a history of psychotropic substance abuse and unable to give up or have mental disorders;
- •Patients who participated in other clinical trials within 4 weeks;
- •have received the VEGFR inhibitors, such as sorafenib and sunitinib;
- •according to the researcher's judgment, there are other accompanying disease endangering the patient's safety or affect the patient to complete the study.
- •patients with central nervous system metastasis;
- •pregnant or lactating women;
- •the researchers consider those who were not suitable for inclusion.
研究组 & 干预措施
First-line treatment
Experimental
First-line treatment：treatment including Mesylate Apatinib Combined With Docetaxel and S-1(DS).DS Docetaxel 75mg/m2 d1 iv.drop 1h（one hour）， S-1(BSA<1.25 40mg Po bid(twice a day), BSA >=1.25-<1.5 50mg Po bid, BSA >=1.5 60mg Po bid), Q21d(21 days a cycle); Mesylate Apatinib 500mg Po QD(once a day) continuous use; until disease deterioration.
干预措施: docetaxel (Drug)
结局指标
主要结局
progress-free survival time
时间窗: 30 months
During the treatment, the investigators will arrange patients to underwent CT and MRI examination on time, evaluating the size and the number of the tumor, to determine whether the disease progress than before; and the time from the start of treatment to the progression is progress-free survival time.
次要结局
- Quality of life(30 months)
- disease control rate(30 months)
- adverse events(up to 28 weeks)
- Overall survival Time(30 months)
- Overall remission Rate(during 6 cycles of chemotherapy (each cycle is 28 days))
研究者
Zhou Fuxiang
Director
Zhongnan Hospital
研究点 (1)
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