NCT03546855Unknown2 期
Clinical Study of Apatinib Mesylate in the Treatment of Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
Anhui Provincial Hospital0 个研究点目标入组 69 人开始时间: 2018年6月1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
- 69
- 主要终点
- Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy.
研究概览
简要总结
To Observe and Evaluate the Efficacy and Safety of Apatinib in Patients With Advanced Cervical Cancer After Radiotherapy and First-line Chemotherapy.
详细描述
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical cancer confirmed by pathology;
- •At least one measuring lesion (RECIST 1.1) or ascites (B ultrasound);
- •Recurrence after the treatment of pelvic radiotherapy and first-line chemotherapy;
- •Baseline blood routine and biochemical indicators meet the following criteria:
- •① ANC ≥ 1.5 × 109 / L;
- •HB ≥ 90g / L;
- •PLT ≥ 100 × 109 / L; ④ ALB≥30g / L;
- •TBIL≤1.5 times the upper limit of normal (ULN); ⑥ ALT and AST<2 × ULN; ⑦ Plasma Cr<1.5 × ULN
- •no blood transfusion , blood products, g-csf and other hematopoietic stimulation factors were used in 14 days ;
- •The expected survival time is longer than 3 months;
- •The pregnancy test (serum or urine)should be carried out for women in childbearing age before 7 days into the group and the results were negative, and willing to use appropriate methods of contraception during the test and after 8 weeks out of group
- •The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance and follow-up.
排除标准
- •Allergies to apatinib and/or its excipients
- •People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with level-1 above coronary heart disease, arrhythmia over class I (including QTc lengthened men > 450 ms, women > 470 ms).
- •According to NYHA standard, Ⅲ ~ Ⅳ cardiac insufficiency, or LVEF < 50%;
- •Various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.);
- •Patients with a clear tendency of gastrointestinal bleeding, including the following situations: local active ulcer lesions, and fecal occult blood (++); Patients with black stool and hematemesis in 2 months;
- •Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency;Hereditary or acquired bleeding and thrombosis tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
- •Long-term unhealed wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer in 4 weeks;
- •With abdominal fistula, gastrointestinal perforation or abdominal abscess;Active patients with HBVor HCV;
- •Active brain metastases, meningitis, cancer patients with spinal cord compression, CT or MRI examination revealed brain or soft meningeal disease (21 days before the drug treatment; the symptoms of patients with brain metastases from stable can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation for no symptoms in cerebral hemorrhage).
- •CT or MRI showed that the tumor lesion was less than 5 mm away from the large vessel, or the lesion invaded local large vessels;
- •Pregnant or lactating women;
- •Patients with a history of psychotropic substance abuse or have mental disorders;
- •According to the researchers' judgment, patients who have serious harm to the patient's safety or affect the patients for completing the research;
- •Subjects considered inappropriate by the researchers.
研究组 & 干预措施
treatment group
Experimental
apatinib 500mg/d po.28d as one cycle
干预措施: Apatinib (Drug)
结局指标
主要结局
Apatinib treating patients with advanced cervical cancer after radiotherapy and first-line chemotherapy.
时间窗: 12 week
The time from the beginning of treatment to observing the progression of the disease or the death of any cause.
次要结局
未报告次要终点
研究者
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