Lung cancer
Conditions
Interventions
with or without RCCEP :Nil
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 or above, regardless of gender; 2. Patients with inoperable lung cancer confirmed by histopathology or cytology; 3. The patients who signed the informed consent voluntarily joined the study; 4. Patients who can be treated with karelizumab determined by the researchers. 5. According to RECIST 1.1, patients with at least one measurable lesion should not have received local treatment such as radiotherapy (if the target lesion located in the previous radiotherapy area is confirmed to have progressed and meets RECIST 1.1 standard, it can also be selected as the target lesion); 6. Patients with ECoG: 0-1; 7. Patients whose expected survival time is more than or equal to 12 weeks; 8. Patients whose functions of important organs meet the following requirements (it is not recommended to use any blood components and cell growth factors 2 weeks before the start of the study treatment) Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L Platelets >= 100 x 10^9 /L Hemoglobin >= 9g / dl; 8 g / dl; Bilirubin = 50ml / min Activated partial thromboplastin time (APTT) and international normalized ratio (INR) < 1.5 x ULN (for anticoagulant therapy with stable dose, such as low molecular weight heparin or warfarin, INR can be selected within the expected therapeutic range of anticoagulant); 9. Fertile female subjects should conduct urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to use effective contraceptive methods from the test period to 3 months after the last administration of karelizumab (control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial and within 3 months after the last administration of karelizumab (from the control group to 180 days after the last administration).
Exclusion criteria
Exclusion criteria: 1. Patients who had been diagnosed with other malignancies within the first 5 years of the first study were treated with effective treatment for basal cell carcinoma, squamous cell carcinoma of the skin, and / or effective resection of in situ cervical cancer and / or breast cancer; 2. Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 3. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy)); The patients with vitiligo or asthma in childhood had been completely relieved and did not need any intervention in adulthood could be included, while the patients with asthma who needed bronchodilator for medical intervention could not be included; 4. Patients with uncontrolled clinical cardiac symptoms or diseases, such as: (1) Heart failure above NYHA grade II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias need clinical intervention. 5. Patients with severe infection (CTC AE > 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia and infection complications requiring hospitalization treatment; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics, except for prophylactic use of antibiotics; 6. Patients with known history or evidence of interstitial lung disease or active non infectious pneumonia; 7. Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA2000 IU/mL or more than 104 copies /ml) or hepatitis C (hepatitis C antibody) were positive, and HCV-RNA was higher than the lower limit of analysis method; 8. Subjects who have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 in the past; 9. Subjects who are known to be allergic to macromolecular protein preparations or any component of karelizumab, or have allergic reactions, hypersensitivity or contraindications to fluorouracil, platinum or any component used in their preparations; 10. Subjects requiring systemic treatment with corticosteroids (> 10mg / D prednisone equivalent dose) or other immunosuppressants within 14 days before the first use of the study drug; 11. The toxicity of previous anti-tumor therapy did not return to < CTCAE grade 1 (except for alopecia) or the level specified in the inclusion / exclusion criteria; 12. Pregnant or lactating women; 13. According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress-free survival; | — |
Countries
China
Contacts
Public ContactXu Xingxiang
Jiangsu Provincial People's Hospital
Outcome results
None listed