lung cancer
Conditions
Sponsors
Oncology Department of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before implementing any test related process; 2. Aged >= 18 and 3 months; 11. Adequate organ function, patients should meet the following laboratory indexes: (1) The absolute neutrophil count (ANC) >= 1.5x109/L in 14 days without using granulocyte colony-stimulating factor; (2) In 14 days without blood transfusion, platelet count >= 100 x 10^9 / L; (3) Hemoglobin > 9g / dL in 14 days without blood transfusion or erythropoietin use; (4) Total bilirubin = 60 ml / min; (7) Good coagulation function was defined as INR or PT <= 1.5 x ULN; (8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) in the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme spectrum was within the normal range (if the researchers judged that there was no clinical significance of simple laboratory abnormalities, they were also allowed to be included in the group); 12. For female of childbearing age, the urine or serum pregnancy test should be conducted within 3 days before the first study drug administration (day 1 of the first cycle) and the result is negative. If the urine pregnancy test results can not be confirmed as negative, blood pregnancy test is required. Women of non reproductive a
Exclusion criteria
Exclusion criteria: 1. The pathology was small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC; 2. The first study drug received radiotherapy before administration, which met one of the following conditions: (1) >= 30% of bone marrow had received radiotherapy within 14 days before treatment (2) Patients received radiotherapy for lung lesions within 6 weeks before treatment and the dose was > 30Gy (the enrolled patients must recover from the toxicity of previous radiotherapy to grade 1 or below, without glucocorticoid treatment and history of radiation pneumonia) (3) The end time of palliative radiotherapy was within 7 days before the first study drug administration; 3. Other malignant diseases (excluding radical basal cell carcinoma of skin, squamous cell carcinoma of skin, and / or radical resection carcinoma in situ) were diagnosed within 5 years before the first administration; 4. Currently participating in interventional clinical research, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 5. Having received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 6. Received systemic treatment with Chinese medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with anti lung cancer indications within 2 weeks before the first administration; 7. Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy; 8. Receiving systemic glucocorticoid treatment within 7 days before the first administration 9. Patients with clinically uncontrollable pleural effusion / peritoneal effusion (those who did not need drainage or had no significant increase in effusion after 3 days of drainage could be enrolled); 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Those who are known to be allergic to the active ingredients or excipients of sintilimab, carboplatin, cisplatin, albumin paclitaxel; 12. Not fully recovered from the toxicity and / or complications caused by any intervention (i.e. <= grade 1 or reaching baseline, excluding fatigue or hair loss) before the start of treatment; 13. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number higher than the upper limit of the normal value in the laboratory of the research center); 15. Active HCV infection (HCV antibody positive and HCV-RNA level higher than the detection limit); 16. Live vaccine was inoculated within 30 days before the first administration (the first cycle, the first day); 17. Pregnant or lactating women; 18. Serious or uncontrollable systemic disease 19. The researchers think that there are other potential risks and they are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;OS;AE;SAE; | — |
Countries
China
Contacts
Public ContactShunchang Jiao
The General Hospital of People's Liberation Army(301 hospital)
Outcome results
None listed