NCT05218759尚未招募不适用
Exosomes Detection for the Prediction of the Efficacy and Adverse Reactions of Anlotinib in Patients With Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- PD
研究概览
简要总结
Exosomes detection for the prediction of the efficacy and adverse reactions of Anlotinib in patients with advanced NSCLC
详细描述
Explore blood exosomal miRNA as a biomarker for predicting the efficacy or risk of serious adverse reactions in patients with advanced lung adenocarcinoma (or lung squamous cell carcinoma) after anlotinib treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have signed informed consent.
- •Male or female, age between 18-75 years old.
- •Patients with advanced lung adenocarcinoma who failed standard treatment.
- •Complete prognostic assessment information.
- •Efficacy evaluation: PR/SD/PD.
- •Anlotinib single drug administration.
- •ECOG PS score: 0-
- •Patient's expected survival time is greater than 12 weeks.
- •The functions of main organs meets the following criteria: 1) absolute neutrophil count (ANC) ≥1.5×10^9/L; 2) white blood cell count (WBC) ≥3.0×10^9/L; 3) platelet (PLT) ≥100×10^9/L; 4) hemoglobin (Hb) ≥90g/L; 5); creatinine clearance ≥50ml/min or serum creatinine (Cr) ≤1.5×upper limit of normal (ULN); 6)serum total bilirubin (TBIL) ≤1.5×ULN; 7) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; 8) left ventricular ejection fraction (LVEF) ≥ the lower limit of the normal (50%); 9) Serum Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 10) ALT and AST ≤ 5ULN; 11) activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN.
- •Women of childbearing age should make sure their pregnancy test is negative within 2 weeks before the study, and keep using contraceptive methods during the study and within 24 weeks after the last administration of Anlotinib. For men, they must agree to use contraceptive methods during the study period and also 24 weeks after the last administration of Anlotinib.
排除标准
- •Patients whose plasma is not qualified for the test (hemolysis, precipitation, etc.)
- •Patients who have used Anlotinib before.
- •Pathological diagnosis results do not meet the requirements for entry.
- •Patients never used TKIs.
- •Patients with hemoptysis, more than 50mL per day.
- •Patients with other kinds of malignancies within 5 years.
- •Patients who have taken systemic therapy (immunotherapy, cytotoxic therapy, or other targeted therapies) within 6 weeks before grouping.
- •Patients who have symptoms of diseases that affect the patient's medication.
- •Patients who have suffered non-relieving toxicity from previous treatment.
- •Patients who have habitus of hemorrhage; the history of ulcer or fracture and non healing wounds.
- •Patients who have suffered arterial/venous thrombosis within 24 weeks.
- •Patients who have been diagnosed with mental disorder.
- •Patients who have suffered other diseases that may affect the patient's life safety and the results of this experiment.
研究组 & 干预措施
arm A
Experimental
Progressive disease (PD) after anlotinib administration
干预措施: Anlotinib (Drug)
arm B
Experimental
Stable disease (SD) after anlotinib administration
干预措施: Anlotinib (Drug)
结局指标
主要结局
PD
时间窗: at the time of 2 months (2 cycles after treatment)
Progressive disease (PD) after anlotinib administration
SD
时间窗: at the time of 2 months (2 cycles after treatment)
Stable disease (SD) after anlotinib administration
次要结局
- Severe adverse reaction group(at the time of 2 months (2 cycles after treatment))
- Adverse reaction non-serious group(at the time of 2 months (2 cycles after treatment))
研究者
Aiqin Gu
Chief physician
Shanghai Chest Hospital
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