lung cancer
Conditions
Interventions
Experimental group:microwave ablation combined with camrelizumab / chemotherapy
Control Group:Camrelizumab/chemotherapy
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed non-small cell lung cancer at the time of initial treatment; 2. Peripheral non-small cell lung cancer with clinical stage IIIB/IIIC and IV (if distant metastasis occurs, it must be oligometastasis); 3. The subjects have not received systemic chemotherapy for advanced NSCLC before; 4. Sensitive mutations of EGFR, ALK, ROS-1 and other driver genes are negative; 5. ECOG score is 0-1; 6. Expected survival period >= 3 months; 7. In addition to ablation lesions, at least one measurable lesion (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is >=10mm, and the short diameter of CT scan of lymph node lesions is >=15mm); 8. Subjects should have never received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 9. Asymptomatic brain metastases or disease control after radiotherapy for brain metastases; 10. There is no significant abnormality in routine laboratory examinations (blood routine, liver and kidney function, coagulation function, etc.): (1) The blood routine examination standards must be met (no blood transfusion and blood products within 14 days): 1) ANC>=1.5x10^9/L; 2) PLT>=80x10^9/L; (2) The biochemical examination shall meet the following standards: a. TBIL45 ml/min (Cockcroft-Gault formula); 11. Sufficient tissue samples can be provided for PD-L1 or TMB testing or blood samples (1 week before treatment, 1 week after ablation, immune evaluation once every two months) for follow-up analysis; 12. Patients with potential fertility need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 1 month after the end of the study treatment period; and Serum or urine HCG test must be negative within 72h before study enrollment, and must be non-breastfeeding; 13. Aged 18 to 80 years; 14. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed lung cancer contains neuroendocrine or small cell lung cancer, sarcoma, etc; 2. Patients with other malignancies (recurrent cancer) within five years; 3. Previous history of allergy to any component of the test drug: carrelizumab; 4. The control of intractable pleural or pericardial effusion was poor; 5. Previously received anti-PD-1 or PD-L1 or CTLA-4 or car-t immunotherapy; 6. Have a history of interstitial lung disease (except for radiation pneumonia not treated with national hormone) and non infectious pneumonia; 7.The subjects had any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism); Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma patients who need bronchodilator for medical intervention could not be included; 8.The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 9.Severe infection (CTCAE > grade 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia and infection complications requiring hospitalization; Baseline chest imaging showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral and intravenous antibiotics, except for the use of prophylactic antibiotics; 10.The subject had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 11.According to NYHA standard, grade III ~ IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) 1.5 APTT>1.5 ULN) and bleeding tendency; 14.Wounds or fractures that have not been cured for a long time; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 15.subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis B reference: HBV DNA detection value exceeded the upper limit of normal value; HCV reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 16.Those who have a history of psychotropic drug abuse and can not give up or have mental disorders; 17.According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 18. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival;Relief maintenance time;disease control rate; | — |
Countries
China
Contacts
Public ContactYang Xia
Shandong Provincial Hospital
Outcome results
None listed