A Single-arm, Exploratory Clinical Trial Investigating the Efficacy of Local Envafolimab Injection Under Fiberoptic Bronchoscopy Combined With Chemotherapy in Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.
详细描述
In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects volunteered to participate in the study, signed the informed consent form, and had good compliance;
- •3.Life expectancy of ≥12 weeks；
- •4.Age ≥18 years;
- •Diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to RECIST 1.1) for advanced central NSCLC;
- •He had not received systemic chemotherapy previously.
- •7.Had at least one measurable tumor lesion according to RECIST v1.1；That is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and the short diameter of a single lymph node on CT scan is ≥15mm；
- •8.Have adequate organ function。
排除标准
- •1.This study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors.
- •Have family history of cancer.
- •3.had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc.
- •4.Only individuals experiencing grade 1 or higher unmitigated toxic effects (excluding alopecia and fatigue) resulting from previous therapies were eligible for enrollment; neurologic toxicity needed to return to grade 1 or lower or baseline before participation.
- •5.Subjects with severe and/or uncontrollable disease progression；
- •6.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- •7.Pregnant or lactating women;
- •8.Other conditions considered unsuitable for this study by the investigator.
研究组 & 干预措施
envafolimab plus chemotherapy
Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.
干预措施: Envafolimab Injection (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Up to 2 years
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1
Overall Survival(OS)
时间窗: Up to 2 years
OS is defined as the time from randomization to death due to any cause.
Progression free survival(PFS)
时间窗: Up to 2 years
Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).
次要结局
- Disease control rate (DCR)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Treatment related adverse events (TRAEs)(from first dose to 30 days post the last dose)
研究者
xu xingxiang
Director
Northern Jiangsu People's Hospital