Clinical efficacy and immune mechanism of yifeiyin in delaying TKI resistance in non-small cell lung cancer

Tongde Hospital of Zhejiang Province0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patient with stage IIIB to IV lung cancer which was diagnosed by CT, MRI, B-ultrasound and other imaging examinations, and confirmed by cytology or pathological examination;
•2. Adopted the ADx-ARMS-EGFR gene mutation detection kit (Xiamen Aide Biomedical Science and Technology Co., Ltd. 21 human EGFR gene mutation detection kits) to be confirmed as EGFR gene sensitive mutation patients undergoing EGFR-TKI treatment;
•3. TCM syndrome differentiation belongs to spleen deficiency phlegm and dampness type;
•4. Can follow the doctor's instructions (take spleen deficiency phlegm and dampness medicine for more than 3 months), insist on taking medicine, good compliance, can understand the situation of this study
•Patients who have signed an informed consent form;
•5. Age 18 to 70 years; PS score <=2 points;
•6. No dysfunction of major organs, normal blood routine, liver, kidney and heart function: hemoglobin >=9 g/L, neutrophil absolute cell count (ANC) >=1.5x10^9/L, platelet >=100x10^9/L, Bilirubin <=1.5 ULN, alkaline phosphatase ((APL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 ULN (if liver metastasis is allowed ALT <=5 ULN ). International normalized ratio (INR) <=1.5 ULN. Activated partial thromboplastin time (APTT) <=1.2 ULN, creatinine <=1.5 ULN.

•1. Have a history of other tumors within 5 years;
•2. Those whose expected survival time is less than 3 months;
•3. Patients with any acute or chronic diseases or mental disorders or abnormal laboratory tests, these combined diseases may increase the risk of participating in research or research medication, or have an impact on the research results. The investigator judges that the patient is not suitable for joining the study,these situations include:(Uncontrolled high blood pressure, unstable angina, myocardial infarction, or symptomatic congestive heart failure or uncontrolled arrhythmia in the past 12 months. Electrocardiogram suggests significant changes in ischemia; bacterial, fungal, or viral infections The active period of the disease; those with dementia or major changes in mental state that make it impossible to understand or express informed consent);
•4. Patients during pregnancy or lactation;
•5. Those who have poor compliance with the protocol and the researchers believe that it is not appropriate to participate in this experiment;
•6. Those who are allergic to drugs or are participating in other drug trials.

发起方

Tongde Hospital of Zhejiang Province