Lung cancer
Conditions
Interventions
experimental group:Carrelizumab combined with irinotecan
Sponsors
Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Extensive-stage small cell lung cancer confirmed by histology or cytology (according to the VALG staging of the American Veterans Lung Cancer Association); 3. ECOG physical fitness score 0-1 points; 4. Imaging progress after receiving first-line standard chemotherapy in the past; 5. There are measurable lesions defined by RECIST standard v1.1; 6. Life expectancy >=8 weeks; 7. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of research and treatment): a. Absolute neutrophil count (ANC) >= 1.5x10^9/L b. Platelets >=100x10^9/L; c. Hemoglobin >=9g/dL; d. Serum albumin >=2.8 g/dL; e. Bilirubin =50mL/min (Cockcroft-Gault). 8. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration and prove to be negative, and are willing to administer carrelizumab during the test period to the last time Use effective methods for contraception within the next 3 months (control group to 180 days after the last medication). For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of Carrelizumab (from the control group to 180 days after the last administration); 9. The subject voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Non-small cell and small cell mixed carcinoma confirmed by histology or cytology; 2. A history or evidence of known interstitial lung disease or non-infectious pneumonia treated with corticosteroids; 3. Severe cardiovascular disease, such as New York Heart Association (NYHA) Grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accidental activity within 3 months before randomization Brain metastasis or meningeal metastasis; 4. Suffer from any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormonal It can be included after the alternative treatment is effective)); patients with vitiligo or asthma that has been completely relieved in childhood and do not require any intervention after adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included; 5. Suffering from congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA =104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit of the analysis method); 6. Clinically significant serous effusion (for example, uncontrolled pericardial effusion, ascites or pleural effusion, through aspiration or other treatments); 7. Known hypersensitivity to the research drug or any of its excipients; known hypersensitivity to any antibody; 8. Treat with any other experimental drugs or participate in another clinical trial within 4 weeks before screening; 9. Women during pregnancy or lactation; 10. As judged by the investigator, it is not suitable for inclusion in patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;QoL; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AE;PFS;DCR; | — |
Countries
China
Contacts
Public ContactMeiyun Zhang
Baotou Cancer Hospital
Outcome results
None listed