NCT05380271尚未招募2 期
Efficacy and Safety of Bronchial Arterial Infusion Chemotherapy Combined With Drug Loaded Microspheres Embolization With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
Gang Wu0 个研究点目标入组 60 人开始时间: 2022年7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
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- PFS
研究概览
简要总结
This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- •Aged >=18 years, <= 85 years;
- •Patients with NSCLC diagnosed by imaging and histopathology; TNM stage was III-IV;
- •Initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy);
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Expected survival period ≥ 3 months.
排除标准
- •Known hypersensitivity to any of the study drugs or excipients;
- •Hypertension that is not controlled by the drug;
- •International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- •WBC count < 3000 /mm3;
- •Platlet count < 50000 /mm3;
- •Poorly controlled diabetes before enrollment;
- •Clinically significant electrolyte abnormalities judged by researchers;
- •Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- •Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade > 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) < 50%;
- •Active infection or serious infection that is not controlled by drug;
- •History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);
- •Women who are pregnant or lactating;
- •Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- •Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
研究组 & 干预措施
sequential DEB-BACE and Arotinib and Tirelizumab
Experimental
- First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
- Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery.
- The third treatment. Arotinib, 8-12mg, oral (stop oral for 1W every 3W).Tirelizumab, 200mg, intravenous drip (every 3W).
干预措施: sequential DEB-BACE and Arotinib and Tirelizumab (Drug)
DEB-BACE alone
Active Comparator
- First treatment. Only infusion chemotherapy (THP + Nedaplatin + Letitrexed), THP 20 ~ 30mg/m2, Nedaplatin 40mg/m2, Letitrexed 3mg/m2.
- Second treatment. After infusion chemotherapy, Callispheres microspheres is used for embolization: Callispheres microspheres (300-500 μ m) 1tube was loaded and adsorbed THP (40 ~ 600mg/m2) End point of embolization: stagnation of blood flow in tumor feeding artery.
干预措施: DEB-BACE alone (Drug)
结局指标
主要结局
PFS
时间窗: up to 3 years
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
次要结局
- ORR(up to 3 years)
- Overall survival (OS)(up to 3 years)
研究者
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University
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