chemotherapy combined with camrelizumab and apatinib in first-line treatment of es-sclc

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: the efficacy of pd-1/pd-l1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. pd-1/pd-l1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.

camrelizumab is a humanized pd-1 monoclonal antibody. camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. median os is 8.4 months. in our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.

Eligibility criteria:
inclusion criteria: * 1. extensive stage small cell lung cancer proved by pathology. * 2. extensive small cell lung cancer does not receive systematic treatment. * 3. limited sclc patients have received radiotherapy and chemotherapy for more than 6 months. * 4. patients have measurable lesions according to recist version 1.1. * 5. male or female who is 18 to 75 years old. * 6. ecog ps 0 or 1. * 7. life expectancy is more than12 weeks. * 8. appropriate organ system function. * 9. hyroid-stimulating hormone is uln or less (if t3 and t4 is normal, he still meets the inclusion criteria even the abnormal tsh. ) * 10. take proper contraceptive measures. * 11. subjects voluntarily participate in this study and sign the informed consent. exclusion criteria: * 1. previous treatment with apatinib, anti-programmed cell death (pd-1), anti-pd-1, or other pd-1/ pd-l1 immunotherapy. * 2. cancer meningitis. * 3. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. * 4. there are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.. * 5. uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage. * 6. patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease ≥1 week before enrollment; * 7. patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade i or above, arrhythmias of grade i or above , or cardiac insufficiency; * 8. subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration. * 9. the adverse events caused by previous treatment did not completely recover. * 10. patients with major surgery or obvious traumatic injury within 28 days before enrollment; * 11. occurred arterial or venous thromboembolism events within 6 months. * 12. people with a history of drug abuse or mental disorders. * 13. suffering from a serious and/or uncontrollable disease; * 14. vaccination or attenuated vaccine received within 4 weeks. * 15. severe allergies that require treatment with other monoclonal antibody drugs; * 16. active autoimmune disease requiring systemic treatment within 2 years prior to the first administration; * 17. immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose; * 18. participate in other anticancer drug clinical trials within 4 weeks; * 19. in the investigator's judgment, there are other factors that may have led to the termination of the study.

Keywords: camrelizumab; apatinib