tracheal tumors
Conditions
Interventions
Case series:neoadjuvant PD1 monoclonal antibody and neoadjuvant chemotherapy combined with radical surgery
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent; 2. Male and female aged >=18 years old; 3. Histologically confirmed non-small cell lung cancer (pathological biopsy required): Diagnostic needle biopsy specimens need to be diagnosed by a specialist pathologist Tumor biopsy samples can be formalin-fixed tissue blocks or 10 5µm tissue sections, which will be used for biomarker evaluation (pathology researchers need to confirm whether the sample is sufficient). These can be preserved samples or, if needed, a new biopsy can be performed to obtain them. 4. ECOG score data 0-1; 5. Good organs function: Absolute neutrophil count >=1.5x10^9/L; Platelet count >=100x10^9/L; Red blood cell count >=2.0x10^9/L; Hemoglobin>=90g/L; Creatinine =60ml/min; Total bilirubin level <=1.5 ULN and aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels <=2.5 ULN; International normalized ratio (INR) or prothrombin time (PT) <=1.5 ULN; if the subject is receiving anticoagulation therapy, as long as the INR/PT is within the proposed range of anticoagulation drugs; Good lung function, can tolerate surgical resection; 6. No systemic metastasis; 7. Women with childbearing potential (WOCBP) and men must agree to use appropriate contraceptive measures (hormonal or barrier contraceptive methods; abstinence) before entering the study and during study participation and within 23 weeks after the last dose of Sintilimab ). Women with childbearing potential (WOCBP) must have a negative serum or urine pregnancy test before taking the drug.
Exclusion criteria
Exclusion criteria: 1. Any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.; 2. There is a history of any primary malignant tumors. 3. Active, known or suspected autoimmune diseases. Subjects with vitiligo, type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or conditions that are not expected to recur without external triggers are allowed to register. 4. Subjects with a history of interstitial lung disease. 5. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before being selected for treatment. A history of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism in the 3 months before enrollment (implantable venous port or catheter-derived thrombosis, or superficial vein thrombosis is not considered "serious" Thromboembolism). 6. An active autoimmune disease that requires systemic treatment (such as the use of disease-improving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; 7. Patients who require long-term systemic use of corticosteroids. Patients who require intermittent use of bronchodilators, inhaled corticosteroids, or local injections of corticosteroids due to COPD and asthma can be included in the group. 8. Known positive medical history or positive test for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS), active tuberculosis. 9. Active hepatitis B without treatment; Note: Hepatitis B subjects who meet the following criteria are also eligible for selection: The HBV viral load must be less than 1000 copies/ml (200 IU/ml) or lower than the lower limit of detection before the first administration. Subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation; For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV therapy, but close monitoring of viral reactivation is required; 10. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the detection limit); 11. Has a history of allergies to the ingredients of the study drug; 12. Women who are pregnant or breastfeeding; 13. Men who have female partners of reproductive potential (WOCBP) who are unwilling to use contraception; 14. Previously treated with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies (or any other antibodies targeting the co-regulatory pathway of T cells); 15. The investigator believes that under current medical conditions, the use of study drugs may make the subject dangerous or obscure the interpretation of toxicity or adverse events; 16. Prisoners or subjects who are involuntarily imprisoned or detained to treat mental or physical (such as infectious diseases) diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival time; | — |
Countries
China
Contacts
Public ContactLiu Xiaogang
Shanghai Pulmonary Hospital
Outcome results
None listed