NCT06104709尚未招募不适用
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma
China-Japan Friendship Hospital0 个研究点目标入组 10 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- cryoablation completion
研究概览
简要总结
The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are:
- local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation.
- local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation.
Peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or metastatic lung cancer with definite pathological diagnosis.
- •Patients are not suitable for thoracotomy due to serious lung or systemic disease.
- •Peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection.
- •There are indications for surgical resection, but the patient refuses surgery.
- •Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum diameter ≤3cm.
- •ECOG-PS score≤
- •Patients with an expected survival of more than three months.
- •Patients have not participated in other clinical validation within 3 months.
- •Subjects voluntarily sign informed consent.
排除标准
- •Serious heart and brain disease or other mental illness.
- •Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
- •Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla.
- •A history of immunodeficiency, including a positive HIV test (enzyme-linked immunoassay and Western spot assay).
- •Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment.
- •There is a serious bleeding tendency, platelets less than 50×109 /L and coagulation function is seriously disturbed.
- •Coagulation index (PT, TT, APTT) > 2.5 times the upper limit of normal.
- •Ablation of ipsilateral malignant pleural effusion is not well controlled.
- •Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorders.
- •Patients with extensive extrapulmonary metastasis are not suitable for ablative therapy.
- •People who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs.
- •Pregnant or breastfeeding women.
- •Patients who cannot evaluate the efficacy.
- •Other conditions determined by the investigators to be unsuitable for inclusion, such as inability to tolerate cryoablation surgery, difficulty in follow-up, and other serious diseases.
结局指标
主要结局
cryoablation completion
时间窗: 1 month
patients complete local cryoablation
次要结局
未报告次要终点
研究者
Gang Hou
Principle Investigator
China-Japan Friendship Hospital
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