ITMCTR2022000049尚未招募早期 1 期
Biological characteristics of Shuangshen granules for early prevention of lung cancer and metastasis and construction of nano-targeted drug delivery system
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •Lung nodule inclusion criteria
- •(1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria.
- •(2) Pulmonary nodules pathologically diagnosed as precancerous lesions such as pulmonary atypical adenomatous hyperplasia, angiogenic squamous epithelial atypia, or carcinoma in situ.
- •(3) Solid nodules, or sub-solid nodules with no significant change at 3-month follow-up.
- •(4) Nodules = 8 mm in size or those who have been closely followed up by a multidisciplinary team.
- •(5) Basic normal function of heart, liver, kidney and hematopoietic system.
- •(6) Age 18 to 75.
- •(7) Karnofsky score = 90.
- •(8) Voluntary participation in this study and signed informed consent form.
- •Inclusion criteria for postoperative patients with non-small cell lung cancer
- •(1) Patients with Qi deficiency and blood stasis evidence combined with the following inclusion criteria.
- •(2) Those with stage I-IIIB non-small cell lung cancer who are 1 month postoperative after conventional radiotherapy.
- •(3) Patients with higher ctDNA level than normal population by NGS test.
- •(4) Those diagnosed by pathology as squamous lung cancer or adenocarcinoma of the lung.
- •(5) Basic normal function of heart, liver, kidney and hematopoietic system.
- •(6) Age 18 to 75 years old.
- •(7) Karnofsky score = 90.
- •(8) Voluntary participation in this study and signed informed consent form.
- •Inclusion criteria for healthy population screening:
- •(1) Age: 18-75;
- •(2) In accordance with the above diagnostic criteria of healthy people, the TCM constitution is determined as peaceful quality;
- •(3) BMI of 18-24kg/m2;
- •(4) There is no abnormality in the physical examination.
排除标准
- •(1) Those who have other gene mutations and need targeted therapy;
- •(2) complicated with other lung diseases (such as hypertension, diabetes, coronary heart disease, chronic obstructive pulmonary disease, asthma, interstitial lung disease, tuberculosis, etc.) and requiring long-term drug use;
- •(3) Patients with other primary tumors outside the lungs;
- •(4) Patients with autoimmune diseases;
- •(5) Long-term use of hormones, anti-inflammatory drugs and immunosuppressants due to disease;
- •(6) Alcoholics;
- •(7) pregnant, trying to get pregnant, breast-feeding or mentally ill;
- •(8) People who are allergic to Chinese medicine ingredients or cannot take Chinese medicine orally;
- •(9) Patients who participated in clinical studies of other drugs or are participating in other clinical studies within 1 month prior to participating in this study;
- •(10) Take other drugs or health food that may affect the test.
研究者
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