Lung cancer
Conditions
Interventions
Experimental group:Carrelizumab combined with apatinib
Sponsors
Baotou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old, both male and female; 2. Extensive-stage small cell lung cancer confirmed by histology or cytology (according to the Veterans Administration Lung Study Group, VALG staging); 3. ECOG physical fitness score 0-1 points; 4. Previously received first-line platinum-based standard chemotherapy regimen for ES-SCLC and imaging progression systemic treatment; 5. There are measurable lesions defined by RECIST standard v1.1; 6. Life expectancy >= 8 weeks; 7. The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of research and treatment): (1) Absolute neutrophil count (ANC) >= 1.5*10^9/L; (2) Platelets >= 100*10^9/L; (3) Hemoglobin >= 9g/dL; (4) Serum albumin >= 2.8g/dL; (5) 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 trial 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 subjects 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 known history or evidence of interstitial lung disease or non-infectious pneumonia treated with corticosteroids; 3. Severe cardiovascular disease, such as New York Heart Association (New York Heart Association, NYHA) grade 2 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or myocardial infarction that occurred within 3 months before randomization Unexpectedly active brain metastases or meningeal metastases from cerebrovascular; 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 (hormone) 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. Suffer from congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >=104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method); 6. Clinically significant third cavity effusion (for example, uncontrolled pericardial effusion, ascites or pleural effusion, through aspiration or other treatment); 7. Known hypersensitivity to the study 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, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, severely abnormal laboratory test values, family or social factors, It may affect the safety of subjects or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;AE;PFS;DCR;QoL.; | — |
Countries
China
Contacts
Public ContactLiping Wang
Baotou Cancer Hospital
Outcome results
None listed