Small Cell Lung Cancer
Conditions
Interventions
Experimental Group:combination of camrelizumab?etoposide and cisplatin concurrent with radiotherapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75, male or female; 2. Patients with localized small cell lung cancer confirmed by histopathology (according to AJCC 8th edition staging); 3. Patients who have received less than or equal to 2 cycles of chemotherapy or new treatment in the past; 4. ECoG score: 0-1; 5. Patients with measurable lesions in accordance with RECIST 1.1 standard (according to RECIST 1.1 standard, the long diameter of tumor lesions on CT scan is greater than or equal to 10 mm, and the short diameter of lymph node lesions on CT scan is greater than or equal to 15 mm); 6. Patients whose life expectancy is more than or equal to three months; 7. Patients who must have adequate lung function; 8. Patients with normal function of main organs meet the following criteria: (1) Blood routine examination: hemoglobin (Hgb) >= 90 g / L; neutrophil count (ANC) >= 1.5 x 10^9 / L; platelet count (PLT) >= 100 x 10^9 / L; (2) biochemical examination: serum albumin (ALB) >= 30 g / L; glutamic pyruvic transaminase (ALT) and aspartate transaminase (AST) < 3 x ULN; total bilirubin (TBIL) <= 1.5 x ULN; creatinine <= 1.5 x ULN; 9. Female subjects with fertility should have negative pregnancy test (serum or urine) results within 14 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug; for men, it should be surgical sterilization or consent to use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug. 10. The patients who volunteered to join the study signed informed consent, good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation; 2. Patients who had previously used immunosuppressive drugs within 14 days before the first use of karelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose of drugs); 3. Patients who are known to be allergic to etoposide, cisplatin, karelizumab or drug excipients, or have serious allergic reactions to other monoclonal antibodies; 4. Patients vaccinated with live attenuated vaccine within 4 weeks before the first administration or during the study period; 5. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) were not included. 6. Patients who received systemic therapy such as bronchodilators were not satisfied with asthma control and could not be included (those who had complete remission of asthma in childhood and did not need any intervention in adulthood could be included). 7. Routine urine examination indicates that urine protein is >= + +, or 24-hour urine protein is more than or equal to 1.0g; 8. Patients who have been diagnosed with any other malignant tumor, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ after adequate treatment; 9. Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 10. Patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above heart failure, poorly controlled arrhythmia (including QTCF interval > 450 ms for male and > 470 MS for female, calculated by fridericia formula) and symptomatic congestive heart failure within 6 months before enrollment; 11. Patients with infection requiring drug intervention within 4 weeks before the first administration (e.g. requiring intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown origin >= 38.5 degrees C during the screening period / before the first administration; 12. Patients with active hepatitis B (HBV-DNA >= 500 IU / ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of detection) or co infection of hepatitis B and hepatitis C; 13. Patients who participated in any other drug clinical study within 4 weeks before the first administration; 14. Patients with known history of psychotropic drug abuse or drug abuse; 15. In patients with other serious physical or mental diseases or abnormal laboratory tests, the risk of participating in the study may be increased, or the results of the study may be interfered with, and the patients considered by the researchers to be unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;overall survival;safety; | — |
Countries
China
Contacts
Public ContactHuiming Jiang
Beijing Cancer Hospital
Outcome results
None listed