Non-small cell lung cancer
Conditions
Interventions
Experimental group:cryoablation combined with camrelizumab and chemotherapy
Control group:camrelizumab combined with chemotherapy
Sponsors
The First Hospital of Qiqihar
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced stage IIIb-IV non-small cell lung cancer diagnosed by pathology or clinical diagnosis; 2. Have never used PD-1 antibody before; 3. At least one measurable tumor lesion that meets RECIST 1.1 criteria; 4. Expected survival period > 3 months; 5. Age: 18-75 years old, male or female; 6. ECOG PS: 0-2 points; 7. The functions of vital organs meet the following requirements: absolute neutrophil count >=1.5x10^9/L, platelets >=80x10^9/L, hemoglobin >=9g/dL; bilirubin 35 g/ml, prothrombin time prolongation 60 mL/min ; 8. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men (having sex with women of childbearing age) must agree to use without interruption during treatment and for 6 months after the last therapeutic dose is administered. contraceptive measures; 9. The patients voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. EGFR gene mutation positive and ALK positive; 2. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Cryoablation treatment cannot be performed: diffuse lung lesions, extensive pleural metastasis with a large amount of pleural effusion, adjacent mediastinal large vessels or tumors around large vessels; 4. The ablation of the lesion surrounding the blood vessel can easily lead to severe bleeding; 5. Lung function is severely impaired, and the maximum ventilation volume is less than 40%; 6. Severe coagulation abnormalities cannot withstand surgery (anticoagulant therapy and/or anticoagulant drug users should stop using them for more than 1 week before ablation therapy); 7. Poor general condition (multiple metastases throughout the body, severe infection, high fever), obvious cachexia, severe insufficiency of important organs, severe anemia, and nutritional and metabolic disorders that cannot be improved in the short term; 8. Uncontrolled, symptomatic brain metastases or people with a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 9. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 10. Patients with active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) who do not need systemic therapy can be included. 11. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 13. Has a history of psychotropic drug abuse, alcohol or drug abuse; 14. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 15. The researcher thinks it is inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;progression-free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactZhou Xin
The First Hospital of Qiqihar
Outcome results
None listed