To Explore the Effect of Immune-induced Stereotactic Body Radiotherapy (SBRT) on Reversing Immunoresistance in Stage IIIc/IV Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- The Overall Response Rate out of the radiation field
研究概览
简要总结
The goal of this clinical trial is to learn about in describe participant population. The main questions it aims to answer are:
the outcomes of the efficacy (ORR) and safety (adverse events, including irAEs, AE, SAEs, and laboratory indicators) of continued immunotherapy in patients with immune-resistant IIIc/IV metastatic NSCLC treated with immune-induced radiotherapy (SBRT).
Participants will be asked to accept the treatment of ICIs regimen and SBRT plan as follows:
ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT treatment, then the first day of each cycle, 21 days as a cycle until disease progression.
SBRT plan: The radiation dose and fractionation of SBRT should be evaluated according to the size and location of the tumor.
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
- •Patients with IIIc/IV NSCLC confirmed by histology and imaging
- •Previous treatment with anti-PD1 or anti-PDL1, and resistantance to ICIs
- •Without standard treatment regimen
- •At least one measurable target (primary tumour or metastasis) according to RECIST v1.1
- •Age ≥ 18 and ≤ 75
- •ECOG PS ≤ 2
- •Life expectancy ≥ 3 months
排除标准
- •Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible)
- •Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses < or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible).
- •Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes
- •Active infection by HBV or HCV Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma
- •Patient with interstitial pneumonitis or pulmonary fibrosis or any other known severe respiratory insufficiency
- •Patient already included in another clinical trial during treatment with an experimental
研究组 & 干预措施
ICIs regimen: tislelizumab 200mg every 3 weeks, the first dose was given 7 days after the last SBRT
干预措施: tereotactic body radiotherapy (Radiation)
结局指标
主要结局
The Overall Response Rate out of the radiation field
时间窗: Individual patients should be evaluated within 3 days after the patient follow-up examination
To evaluate the efficacy of this protocol，Measurements were based on recist1.1
次要结局
未报告次要终点
研究者
Xiong Yanli, MD
Associate Medical Director, Oncology
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University