Efficacy and Safety of Multimode Thermal Therapy in the Treatment of Early Peripheral Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Complete ablation rate at 6 months post-procedure
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of multimode thermal therapy for early peripheral lung cancer, and to explore the changes of systemic immune microenvironment after multimode thermal therapy.
详细描述
This is a single-center, single-arm, exploratory study, and is expected to enroll a total of 10 patients. The enrolled patients were stage IA lung cancer patients with lung lesions found on chest CT, pathologically diagnosed as non-small cell lung cancer, negative for driver gene mutations, and who were considered high-risk or refused surgery by multidisciplinary evaluation. Follow-ups are performed after the multimode thermal therapy. The primary endpoint is complete ablation rate at 6 months after multimode thermal therapy. The secondary endpoints are complete ablation rate at 12 months after multimode thermal therapy, local control rate at 1, 2, 3 years post-procedure, progression-free survival and mmune effects after multimodal thermal therapy.
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
- •Age ≥18 years old;
- •Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested clinical staging as T1N0M0, stage IA (including new-onset lung cancer after surgery and multiple primary lung cancer);
- •The ECOG PS score is 0-2;
- •Expected survival ≥6 months;
- •Negative driver gene mutation: driver genes were defined as EGFR, ALK, ROS1, RET;
- •Agree to undergo multimode thermal therapy as initial treatment after being assessed unsuitable for surgery or refusing surgery, and sign informed consent.
排除标准
- •Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- •Patients whose chest CT indicated that the lung lesions could not be reached through the chest wall through multimode thermal therapy;
- •Severe liver and kidney function and coagulation function abnormalities, platelet count <70×109/L;
- •Poor control of malignant pleural effusion;
- •Patients who have received other anti-tumor drugs or have used immune checkpoint inhibitors in the past 6 months;
- •The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
- •Those who have undergone surgical operations or had allogeneic organ transplants within 1 month;
- •Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
- •Pregnant and lactating women;
- •Long-term use of steroid;
- •Other circumstances considered inappropriate for participation in this study.
结局指标
主要结局
Complete ablation rate at 6 months post-procedure
时间窗: 6 months
This refers to the proportion of completely ablated lesions in the total ablated lesions at 6 months after multimode thermal therapy.
次要结局
- Immunological response (lymphocyte phenotypes, PD-L1 expression, cytokines)(3 months)
- Local control rate at 1, 2, 3 years post-procedure(3 years)
- Progression-free survival(3 years)
- Number of participants with adverse events(1 month)
- Complete ablation rate at 12 months post-procedure(12 months)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital