Based on the 'Hu-Chang' theory and TGF-beta/Smad pathway toto explore the impact of different cryoablation ranges of lung cancer on the tumor immune microenvironment
- Conditions
- ung cancer
- Registration Number
- ITMCTR2000004114
- Lead Sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Aged >=18 years old;
(2) Non-small cell lung cancer diagnosed by cytology or histopathology;
(3) According to the eighth edition of the TNM staging system for lung cancer published by the International Association for the Study of Lung Cancer (IASLC), it is classified as stage IIIb or stage IV;
(4) There is at least one cryoablation lesion with a diameter of 3cm<5cm;
(5) ECOG score: 0 to 2 points;
(6) Expected survival time: >3 months;
(7) No history of combined immune-related diseases or other tumors.
(8) Volunteer to participate and sign the informed consent form.
(1) Neutrophil count<1.5x10^9/L, white blood cell<3.0x10^9/L or>10x10^9/L, platelet<50x10^9/L, or hemoglobin<90g/L;
(2) Fever and body temperature above 38? or obvious active infection occurred within two weeks;
(3) Obvious cardiovascular abnormalities or hypertension not controlled by drugs;
(4) Serum bilirubin is higher than 1.5 times the upper limit of the normal reference range;
(5) Serum muscle liver is higher than 1.5 times the upper limit of the reference range of normal value or the muscle liver clearance rate is less than 50ml/min;
(6) ALT or AST>2.5 times the upper limit of the normal value in the absence of liver metastasis, or 5 times the upper limit of the reference range of normal value in the case of liver metastasis;
(7) Malignant pleural effusion, pericardial effusion or abdominal effusion that is difficult to control;
(8) Pregnant or lactating women;
(9) HBV or HCV antibody positive;
(10) HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CD4+T content;Treg content;Treg/CD4+T;TGF-beta 1 content;
- Secondary Outcome Measures
Name Time Method Overall survival, postoperative survival, and progression-free survival of patients with different ranges of cold ablation;The incidence of adverse reactions in patients with different cold ablation ranges;Quality of life of patients with different cold ablation ranges;