Stage I/II lymph node-negative (T1 to T3N0M0) non-small cell lung cancer.
Conditions
Interventions
Experimental Group:SBRT combine with sintilimab
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Age>=18 years old and 3 months; 9. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) was >=1.5x10^9/L; 2) In the case of no blood transfusion in the past 14 days, platelet >=100×10^9/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; 4) total bilirubin =60 ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).
Exclusion criteria
Exclusion criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer with mixed SCLC and NSCLC; 2. Tumor size>7cm; 3. Patients whose tumors involve the main bronchus or related blood vessels or whose tumors invade any of the key structures (e.g., esophagus, brachial plexus, heart, large mediastinal vessels) are not candidates for SBRT; 4. Diagnosis of other malignant disease other than NSCLC within 5 years prior to the first dose (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); 5. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 6. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137); 7. Received systemic systemic therapy with anti-NSCLC indications of proprietary Chinese medicines or immunomodulatory drugs (including thymus peptides, interferons, interleukin, except for topical use for the control of pleural effusion) within 2 weeks prior to the first dose; 8. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying medications, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 9. Systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent) are allowed; 10. Presence of clinically uncontrollable pleural effusion/ascites effusion (subjects who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in the effusion may be enrolled); 11. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Known hypersensitivity to the active ingredients or excipients of PD-1 inhibitors of this study drug; 13. Have not recovered adequately from toxicity and/or complications caused by any intervention prior to initiation of treatment (i.e., <= grade 1 or to baseline, excluding fatigue or alopecia); 14. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 15. Untreated active hepatitis B (defined as HBsAg positivity with detected HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation; 2) subjects with anti-HBc( ), HBsAg(-), anti-HBs(-), and HBV viral loads (-) do not require prophylactic anti-HBV therapy, but need to be closely monitored for viral reactivation; 16. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 17. Vaccination of a live vaccine within 30 days prior to the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival (EFS)(2y); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJindong Guo
Shanghai Chest Hospital
Outcome results
None listed