lung cancer
Conditions
Interventions
group1:carrelizumab
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate and sign the informed consent in person. 2.Patients confirmed by histology or cytology at the time of enrollment. 3.Age >=18 years old,=3 months. 6.The patient was initially treated with histopathologically confirmed stage III non-small cell lung cancer (NSCLC), EGFR/ALK mutation-negative, locally advanced, non-resectable (according to IASLC/UICC TNM stage 8). 7.At least one measurable lesion (according to RECIST V1.1). 8.Patients must have good organ function, as evidenced by meeting the following screening period laboratory test values within 7 days prior to the first study treatment: (1) Patients do not require blood transfusion or growth factor support within 14 days prior to the following blood sample collection during the screening period and: 1) Neutrophil absolute count (ANC) >= 1.5 × 10^9/L 2) Platelet >=100 × 10^9/L 3) Hemoglobin >=9 g/dL or >=5.6 mmol/L (2) Serum creatinine = 50 mL/min (Cockcroft-Gault formula) (3) Serum total bilirubin <= 1.5 × upper limit of normal (ULN) (Total bilirubin must be < in Gilbert syndrome;3 x ULN) (4) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria will not be included in this study: 1.NSCLC with EGFR-sensitive mutations. 2.NSCLC with ALK gene translocation. 3.Prior antibody or drug therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or any other specifically targeted T-cell costimulation or checkpoint pathway. 4.Prior chemotherapy, radiotherapy, targeted therapy, biotherapy, immunotherapy or experimental drugs used to control locally advanced NSCLC. 5.The patient's radiotherapy plan included the total volume (V20) of the whole lung receiving a dose of >= 20 Gy greater than 38% of the lung volume. 6.Patients with active autoimmune diseases or a history of autoimmune diseases that are likely to recur. Note: Patients with the following diseases cannot be excluded and can be further screened: (1) Well controlled type 1 diabetes (2) Hypothyroidism (if controlled with hormone replacement therapy alone) (3) Well-controlled celiac disease (4) Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss) (5) Any other disease that is not expected to recur in the absence of an external trigger. 7.Any active malignancy, other than non-small cell lung cancer and locally recurrent cancers that have been cured (e.g., radical basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, or breast cancer) less than 2 years before the first administration of the study drug. 8.Corticosteroids are required within 14 days prior to initial administration of the study drug (& GT;10 mg/ day equivalent dose of prednisone) or other immunosuppressive drugs on systemic therapy. Note: Patients with current or previous use of any of the following steroid regimens may be selected: (1) Epinephrine substitute steroid (prednisone Grade 1 potassium, sodium, or corrected calcium laboratory test results are abnormal or >= grade 3 hypoalbuminemia. 10.Poorly controlled pleural effusion, pericardial effusion or ascites requiring frequent drainage (recurrence within 2 weeks after intervention). 11.A history of interstitial lung disease, lung inflammation (non-infectious) or poorly controlled lung diseases (including pulmonary fibrosis and acute lung disease).Patients with significantly impaired lung function or who require oxygen at baseline must have their lung function assessed at screening time. 12.Infections requiring systemic antibacterial, antifungal or antiviral therapy (including tuberculosis infection, etc.) occurred within 14 days prior to initial administration of the study drug. Note: Patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection are permitted to receive antiviral therapy. 13.the presence of untreated chronic hepatitis B or HBV DNA> at the time of screening;500 IU/mL (& gt;2500 copies /mL) of chronic HBV carriers. Note: Non-active hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA & LT;500 IU/mL or & lt;2500 copies /mL) c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactLinxiaodan
Outcome results
None listed