non-small cell lung cancer
Conditions
Interventions
experimental:Carrilizumab combined with SBRT
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand this research and voluntarily sign the informed consent form; 2.Aged from 18 to 70 years; 3.Histopathologically diagnosed as a stage IV non-small cell lung cancer patient with negative driver gene; 4.Have at least 5 separate (primary/metastatic) lesions of which one is amenable for irradiation with a size of = 6 months; 8.Demonstrate adequate organ function: (1)Routine blood examination standards must meet the following requirements (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1)Hemoglobin >=100 g/L; 2)ANC >= 1.5x10^9/L; 3)PLT >= 100x10^9/L; (2)The results of biochemical inspections must meet the following standards: 1)Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); 4)Routine urine test results show urine protein (UPRO) = lower limit of normal value (50%); (4)Activated Partial Thromboplastin Time <=1.5 x ULN; 9.Females should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, serum or urine pregnancy test is negative within 7 days before study enrollment, and they must be non-lactating patients; males should agree to Patients who must use contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to therapeutic drugs; 2. Have known but untreated driver mutations of the EGFR gene or ALK translocation; 3. Histological or cytological confirmation of mixed NSCLC, neuroendocrine carcinoma and sarcomatoid carcinoma; 4. Patients with active brain metastases; 5. Other malignant tumors have been diagnosed within 5 years before entering the study, except for effective treatment of skin basal cell carcinoma, skin squamous cell carcinoma, and effective excision of cervical cancer in situ and/or breast cancer; 6. Vaccination with live attenuated vaccine within 30 days of the first medication or expected within the study period; 7. The patient has active lung, pericardial or systemic infection; 8. Have any active autoimmune disease or history of autoimmune disease; 9. Have received major surgery within 4 weeks before enrollment in the study, or the surgical wound has not healed completely; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 11. Have a history of psychotropic drug abuse and cannot be quit or have a mental disorder; 12. Allergic to gadolinium or suffering from claustrophobia or other factors without MRI enhanced examination; 13. Any unstable systemic diseases: including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that started within the last 3 months, congestive heart failure (New York Heart Association [NYHA] >= Grade II), myocardial infarction occurred within 6 months before enrollment, severe arrhythmia requiring medical treatment, etc; 14. Have a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 15. Currently participating in interventional clinical research treatment, or received treatment with other experimental drugs or research devices within 4 weeks before the first administration; before the first administration, no toxicity and/or complications caused by any intervention Full recovery (ie, =1x10^3/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>=1x10^3/ml), or liver cirrhosis; 17. There are high-risk factors such as bleeding, fistula, perforation and other complications of radiotherapy; 18. The short diameter of residual hilar or mediastinal lymph nodes in CT examination> 1cm; 19. According to the judgment of the investigator, patients who are deemed unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Contacts
Public ContactGe Hong
Henan Cancer Hospital
Outcome results
None listed