NCT04371796Unknown2 期
Exploratory Efficacy and Safety Study of PD-1 Inhibitor Sintilimab (IBI308) in the Neoadjuvant Treatment of Patients With Resectable II-IIIA NSCLC
Sichuan Cancer Hospital and Research Institute0 个研究点目标入组 20 人开始时间: 2020年5月10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
- 20
- 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 Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC
详细描述
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
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 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;
- •Histologically or cytologically confirmed NSCLC (stage II-IIIA, American Joint Committee on Cancer, eighth edition) that was surgically resectable;
- •Being treatment-naive and the diameter of primary tumor was greater than or equal to 1 cm;
- •ECOG performance status score: 0-1;
- •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;
- •PD-L1 expression level ≥ 1%；
- •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;
- •The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose>10 mg / day of prednisone or other therapeutic hormones);
- •History of interstitial lung disease;
- •Severe allergic reactions to other monoclonal antibodies;
- •Previous allogeneic organ transplantation or hemopoietic stem cell transplantation;
- •Have clinical symptoms or disease that are not well controlled ;
- •Grade III to grade IV congestive heart failure;
- •Uncontrolled hypertension;
- •Artery thrombosis, embolism, or ischemia within 6 months before study treatment;
- •Coagulation disorders;
- •Active and uncontrolled infection;
- •The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
- •Any other known malignant tumor;
研究组 & 干预措施
Sintilimab injection
Experimental
- Drugs: Eligible patients received two doses of intravenous sintilimab (200 mg) every 3 weeks (Q3W). Each infusion time is 30-60min.
- Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 6-8 weeks after the first dose.
干预措施: Sintilimab injection (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 Sintilimab Injection
次要结局
- Disease Control Rate (DCR)(up to 2 years)
- Disease-free survival (DFS)(up to 2 years)
- Overall response rate (ORR)(up to 2 years)
- Incidence of irAEs(up to 2 years)
- Incidence of SAEs(up to 2 years)
研究者
Juan LI, MD
MD
Sichuan Cancer Hospital and Research Institute
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