NCT04133337Unknown1 期
One-arm Exploratory Study on the Efficacy and Safety of Apatinib Combined With SHR-1210 Injection (PD-1 Antibody) in the Treatment of Removable IB-IIIA Non-small Cell Lung Cancer
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Major pathologic response rate(MPR)(<10% viable tumor cells)
研究概览
简要总结
The aim of this study was to investigate the safety and efficacy of SHR-1210 in combination with the anti-vascular survival target drug apatinib in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with the period IB-IIIA NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years old to 75 years old, male or female;
- •Initial treatment of patients with IB-IIIA non-small cell lung cancer who are expected to be surgically resected;
- •Histopathologically confirmed non-small cell lung cancer with measurable tumor lesions (spiral CT scan≥10mm, meeting RECIST 1.1 criteria);
- •ECOG PS: 0-1 points
- •The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal.
- •Estimated survival time≥3 months;
- •Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and are shown to be negative ,and willing to be 3 months after the last dose of SHR-1210 injection during the trial period. The effective method was used for contraception (from the control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective methods should be used during the test period and within 3 months after the last administration of SHR-1210 injection (control group to 180 days after the last administration);
- •Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.
排除标准
- •The patient has any active autoimmune disease or a history of autoimmune disease;
- •2.The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose>10 mg / day of prednisone or other therapeutic hormones);
- •3.Interstitial pneumonia ;
- •4.Severe allergic reactions to other monoclonal antibodies ;
- •5.Suffering from high blood pressure and not being well controlled by antihypertensive medication (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg) ;
- •6.Have clinical symptoms or disease that are not well controlled ;
- •7.Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin;
- •8.There was significant coughing blood in the first 2 months before enrollment, or daily hemoptysis amounted to 2.5ml or more;
- •9.Significant clinically significant bleeding symptoms or a clear tendency to hemorrhage during the first 3 months of randomization;
- •10.Urinary routine suggests urinary protein≥ ++ and confirmed 24-hour urine protein> 1.0 g ;
- •11.The patient has active infection, unexplained fever within 3 days before administration, ≥38.5 °C, or baseline white blood cell count>15×109/L;
- •12.The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
- •13.Other patients considered by the treating physician not suitable for inclusion .
研究组 & 干预措施
Apatinib Combined With SHR-1210 Injection
Experimental
- Drugs:Apatinib Apatinib mesylate tablets 250 mg qd po, discontinued one week before surgery.
- Drugs: SHR-1210 SHR-1210 injection 200mg (5mL), ivgtt, q2w, 3 cycles, each time 20-60min completed infusion.
- Surgery:
The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose.
干预措施: Apatinib (Drug)
Apatinib Combined With SHR-1210 Injection
Experimental
- Drugs:Apatinib Apatinib mesylate tablets 250 mg qd po, discontinued one week before surgery.
- Drugs: SHR-1210 SHR-1210 injection 200mg (5mL), ivgtt, q2w, 3 cycles, each time 20-60min completed infusion.
- Surgery:
The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose.
干预措施: SHR-1210 (Drug)
结局指标
主要结局
Major pathologic response rate(MPR)(<10% viable tumor cells)
时间窗: At time of surgery
To assess the major pathologic response rate (\<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 Injection.
次要结局
- Disease-free survival (DFS)(up to 2 years)
- Disease Control Rate (DCR)(up to 2 years)
- Overall response rate (ORR)(up to 2 years)
研究者
Juan LI, MD
MD
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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