NCT04790539Unknown2 期
an Single Arm, Single Center Phase II Clinical Study of Shr-1210 Combined With Paclitaxel-albumin and Carboplatin in the First-line Treatment of Extensive Stage Small Cell Lung Cancer
Shanghai Pulmonary Hospital, Shanghai, China0 个研究点目标入组 71 人开始时间: 2021年4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
- 71
- 主要终点
- 6-month PFS rate
研究概览
简要总结
This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
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
- •18 to 75 years old
- •Confirmed diagnosis of Extensive small cell lung cancer
- •Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
- •The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10^9/L, ANC≥1.5×10^9/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
- •have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
- •The estimated survival period is more than 8 weeks
- •The subjects voluntarily joined the study, signed informed consent,
排除标准
- •Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
- •Leptomeningeal diseases
- •Uncontrolled or symptomatic hypercalcemia
- •Active, known or suspected autoimmune diseases
- •have received any T cell co stimulation or immune checkpoint therapy
- •Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
- •Subjects had active infections
- •Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
- •Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
- •According to the researcher's judgment, there are other factors that may lead to the termination of the study
研究组 & 干预措施
SHR-1210+Paclitaxel-albumin+Carboplatin
Experimental
SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip.
干预措施: SHR-1210 (Drug)
结局指标
主要结局
6-month PFS rate
时间窗: up to 24 months
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
次要结局
- Progression-Free Survival(PFS)(Up to approximately 24 months)
- Overall Survival(OS)(Up to approximately 24 months)
- Number of Subjects with treatment-related adverse events (AEs)(Up to approximately 24 months)
- Overall Response Rate (ORR)(Up to approximately 24 months)
研究者
Caicun Zhou
Prof. Caicun Zhou
Shanghai Pulmonary Hospital, Shanghai, China
相似试验
已完成
不适用
SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic CancerPancreatic Cancer Stage IVNCT04181645RenJi Hospital40
Unknown
2 期
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic CancerPancreatic CancerNCT04814485Tianjin Medical University Cancer Institute and Hospital39
Unknown
2 期
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Hypofraction Radiotherapy in Patients With NSCLCNon-Small-Cell Lung CancerNCT03557411Shandong Cancer Hospital and Institute42
已完成
2 期
Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric CancerGastric CancerNCT02229058Sun Yat-sen University73
终止
3 期
A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC.Non-squamous Non-small-cell Lung CancerNCT04619433Jiangsu HengRui Medicine Co., Ltd.48