| Eligibility |
Inclusion Criteria:
1.Have fully understood and voluntarily signed the informed consent for this study 2.18-75
years old 3.Stage IIIB-IV non-small cell lung cancer patients with histologically or
cytologically confirmed EGFR/ALK- 4.No previous systemic antitumor therapy for the target
lesion 5.ECOG score is 0-2 6.The predicted survival time was =3 months 7.At least one
measurable lesion (according to RECIST 1.1) other than the lesion that underwent microwave
ablation 8.The function of major organs is normal, and the test results during screening
must meet the following requirements:
1. Blood routine (no blood transfusion, erythropoietin (EPO), granulocyte
colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor
(GM-CSF) treatment within 14 days before screening) :
A. Hemoglobin (Hb) = 90 g/L; B. Neutrophil count (ANC) = 1.5×109/L; C. Platelet count
(PLT) = 80 ×109/L;
2. Biochemical tests shall meet the following standards:
A. Total bilirubin (TBIL) < 1.5 ULN; B. Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) < 2.5 ULN and < 5 ULN in patients with liver metastases; C.
Serum creatinine (Cr) = 1.5 ULN or endogenous creatinine clearance > 50ml/min
(cockcroft-gault formula); D. Urine routine test results showed urinary protein (UPRO)
< 2+ or 24-hour urinary protein quantification <1g;
3. Echocardiography: left ventricular ejection fraction (LVEF) =50%;
4. Coagulation function: activated partial thromboplastin time (APTT), international
normalized ratio (INR), prothrombin time (PT) =1.5×ULN; 9. Contraception: Women of
reproductive age should agree that they must use effective contraception during and
for 6 months after the study; Had a negative serum or urine pregnancy test within 7
days before study enrollment and had to be non-lactating; Men should agree to use
contraception during the study and for 6 months after the end of the study
Exclusion Criteria:
1. Allergic to treatment drugs;
2. EGFR/ALK mutation positive;
3. There are high risk factors for local treatment complications such as bleeding,
fistula and perforation;
4. Patients with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation
pneumonitis, drug-induced pneumonitis and severe pulmonary function impairment
(maximum volume < 40%);
5. Patients with coagulopathy who have severe bleeding tendency and cannot be corrected
in a short time (prothrombin time >18 s, prothrombin activity <40%);
6. Anticoagulant therapy and/or antiplatelet drugs (except dabigatran, rivaroxaban and
other new oral anticoagulants) were stopped for no more than 5 to 7 days before
ablation.
7. Extensive pleural metastases with massive pleural effusion;
8. Patients with active brain metastases: untreated, newly diagnosed and/or growing
lesions or symptomatic brain metastases (patients with stable symptoms after treatment
of brain metastases were eligible to remain stable for at least 4 weeks);
9. Infection and radiation inflammation around the lesion, skin infection at the puncture
site without good control, systemic infection, high fever >38.5 ?;
10. Subjects with active autoimmune disease or a history of autoimmune disease, or active
hepatitis B/C. Note: Subjects with hepatitis B who met the following criteria were
also eligible for inclusion: The HBV viral load must be less than 104 copies per
milliliter (2000IU per milliliter) before the first dose, and subjects should receive
anti-hbv therapy to avoid virus reactivation throughout the study drug treatment. For
subjects with anti-HBC (+), HBsAg (-), anti-HBs (-), and HBV viral load (-),
prophylactic anti-HBV therapy is not required, but close monitoring of viral
reactivation is required;
11. Patients were using immunosuppressive agents or systemic hormone therapy (dose >10mg/
day prednisone or other efficacy hormone) to achieve immunosuppression and continued
to use them within 2 weeks before enrollment;
12. Has had or is currently suffering from other malignant tumours within 5 years, except
cured cervical carcinoma in situ, non-melanoma skin cancer or other tumours/cancers
that have undergone radical treatment and have shown no signs of disease for at least
5 years; 65/5000
13. Had received antitumor drug therapy (e.g., chemotherapy, hormone therapy,
immunotherapy, antibody therapy, radiotherapy, etc.) 4 weeks before or within 4 weeks
of the first dose, with the exception of palliative radiotherapy to bone for pain
relief;
14. Had undergone major surgery within 4 weeks before the first dose or was expected to
undergo major surgery during the study;
15. Patients whose imaging showed that the tumor had invaded important blood vessels or
who were judged by the investigator to be highly likely to invade important blood
vessels during the subsequent study and cause fatal massive bleeding;
16. Clinically significant cardiovascular disease, including but not limited to acute
myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass
grafting within 6 months before enrollment; New York Heart Association (NYHA) grade of
congestive heart failure =2; Arrhythmia (including QTc interval = 450 ms in men and =
470 ms in women); Left ventricular ejection fraction (LVEF) <50%;
17. Those who have a history of psychotropic drug abuse and are unable to quit or have
mental disorders;
18. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
19. Those who received live attenuated vaccine within 30 days of the first dose or
expected to receive live attenuated vaccine during the study period;
20. The subject has received or plans to receive solid organ or blood transplantation
(except corneal transplantation) during the study;
21. Patients deemed ineligible for enrollment in the investigator's judgment;
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