Non-small cell lung cancer
Conditions
Interventions
Experimental group:Cryoablation followed by adebrelimab and chemotherapy
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender not limited; 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 3.Life expectancy exceeding 3 months; 4.Histologically or cytologically confirmed non-small cell lung cancer, TNM stage IIIb-IV (judged according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) Staging Manual for Thoracic Oncology); 5.No EGFR sensitive mutations and no ALK or ROS1 gene rearrangements; 6.According to RECIST 1.1 criteria, the patient must have at least one measurable target lesion (tumor lesion CT scan long diameter >= 10 mm, lymph node lesion CT scan short diameter >= 15 mm, scan layer thickness not greater than 5 mm); 7.Effective first-line treatment with ICS (defined as partial response or complete response or stable disease for more than 6 months) and oligoprogression; 8.Oligoprogression is defined as the number of extracranial progressive lesions = 1.5×10^9/L; PLT >= 90×10^9/L; Hb >= 90 g/L; TBIL = 50 mL/min (Cockcroft-Gault formula); LVEF >= 50%; Fridericia-corrected QT interval (QTcF) < 450 ms for men and < 470 ms for women; INR <= 1.5×ULN, ACTT <= 1.5×ULN. 10.Women of childbearing age must undergo a serum pregnancy test within 7 days before the first dose of the drug, and the result must be negative. Women of childbearing age and male subjects whose partners are of childbearing age must agree to use contraception from the time of signing the informed consent form until 24 weeks after the last administration of the study drug; 11.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1.Histological diagnosis of small cell lung cancer; 2.Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first dose; 3.Allergic to any component of the investigational drug; 4.Active brain metastases; asymptomatic brain metastases patients can be enrolled; for patients with clinically suspected central nervous system metastases, a CT or MRI scan must be performed within 28 days before enrollment to rule out central nervous system metastases; 5.History of unstable angina; newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmia (including QTcF: >= 450 ms for males, >= 470 ms for females) requiring long-term use of antiarrhythmic drugs and New York Heart Association functional class >= II; 6.Urinalysis indicates proteinuria >= ++ and confirmed 24-hour urine protein quantification >1.0 g; 7.Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, and other conditions requiring the use of corticosteroids; with a history of chronic autoimmune diseases, such as systemic lupus erythematosus, etc.; with a history of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, or chronic diarrhea diseases such as irritable bowel syndrome; with a history of sarcoidosis or tuberculosis; with active hepatitis B, hepatitis C, or HIV infection; 8.History of abuse of psychotropic drugs and inability to quit or with mental disorders; 9.Presence of pleural effusion or ascites with clinical symptoms requiring clinical intervention; 10.According to the investigator's judgment, there are serious concomitant diseases that pose a significant risk to the patient's safety or affect the patient's ability to complete the study; 11.Other situations deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Obeject Response Rate;Safety;Overall Surviva;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactLingxiang Liu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed