Small Cell Lung Cancer
Conditions
Interventions
Single group:Carrizumab plus apatinib plus chemotherapy
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >= 18 years; 2. ES-SCLC confirmed by histology and cytology (according to the US Veterans Administration Lung Cancer Association (VALG) disease staging system); 3. No previous systemic treatment with ES-SCLC; 4. Patients with asymptomatic CNS metastases who have been previously treated can participate in this study as long as they meet all of the following criteria: only supra-curtain metastases and cerebellar metastases (ie, no metastasis in the midbrain, pons, medulla oblongata, or spinal cord) , No need for continuous corticosteroid treatment for CNS diseases; 5. According to the RECIST 1.1 standard, the patient has at least one target lesion with measurable diameter (the longest CT scan of tumor lesions >= 10 mm, the shortest CT scan of lymph node lesions >= 15 mm, and the scan layer thickness not more than 5 mm); 6. When the patients were enrolled, the World Health Organization (WHO)/Eastern United States Oncology Collaboration Group (ECOG) physical fitness score (PS) was 0 or 1; 7. Satisfy sufficient hematology and peripheral organ function defined by the following laboratory test results, these test results must be completed within 14 days before enrollment: ANC >= 1500 cells/µL, and have not received granulocyte colony-stimulating factor support therapy, Lymphocyte count >= 500/µL, platelet count >= 100,000/µL, and no blood transfusion, hemoglobin >= 9.0 g/dL, patients can reach this standard through blood transfusion. INR or aPTT <= 1.5 * upper limit of normal (ULN), this standard is only applicable to patients who are not currently receiving anticoagulant therapy; AST, ALT and alkaline phosphatase <= 2.5 * ULN, except for: patients with confirmed liver metastases : AST and/or ALT <= 5 * ULN, patients diagnosed with liver or bone metastases: alkaline phosphatase <= 5 * UL, serum bilirubin <= 1.25 * ULN, patients with known Gilbert disease are allowed to have serum biliary red Prime level <= 3 * ULN. Serum creatinine <= 1.5 * ULN; 8. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis , Nephritis, hyperthyroidism, and decreased thyroid function; subjects with vitiligo or asthma that has been completely relieved in childhood can be included without any intervention after adulthood; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 2. There are active infections, such as: active hepatitis B (chronic or acute; defined as positive screening results of hepatitis B virus surface antigen [HBsAg]) or patients with hepatitis C, previous hepatitis B virus (HBV) infection or HBV infection has been cured Patients (defined as hepatitis B core antibody [HBcAb] positive and HBsAg negative) can participate in this study. 3. Suffering from severe cardiovascular diseases, such as New York Heart Association heart disease (grade II or higher), myocardial infarction occurred within 3 months before random allocation, cerebrovascular accident, unstable arrhythmia, unstable angina , Patients who are known to have coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction 10mg/day prednisone or other therapeutic hormones), and within 2 weeks before enrollment Still in use; 9. Severe allergic reaction to chimeric or humanized antibody or fusion protein, allergic reaction or allergy to carboplatin or etoposide; 10. There are mental illnesses/social conditions that limit compliance with research requirements, significantly increase the risk of AEs, or affect the ability of patients to provide written informed consent; 11. Women who are pregnant or breastfeeding; 12. The investigator determines that other circumstances are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactLiu Yong
Xuzhou Central Hospital
Outcome results
None listed