Extensive-Stage Small Cell Lung Cancer
Conditions
Interventions
Sponsors
The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system); 3. No prior systemic treatment for ES-SCLC; 4. Patients with previously treated asymptomatic CNS metastases can participate in this study as long as they meet all of the following criteria: only supra-cancerous and cerebellar metastases (ie, no metastases to the midbrain, pontine, medulla or spinal cord), Continuous corticosteroid treatment for CNS disease Eastern Cooperative Oncology Group performance status of 0 or 1; 5. According to the RECIST 1.1 standard, the patient has at least one measurable target lesion (CT scan of tumor lesions with a long diameter of >= 10 mm, CT scan of lymph node lesions with a short diameter of >= 15 mm, and the scan layer thickness is not greater than 5 mm). 6. When the patients were enrolled, the World Health Organization (WHO) / Eastern Oncology Collaborative Group (ECOG) Physical Performance Score (PS) was 0 or 1. 7. Adequate hematology and peripheral organ function as defined by the following laboratory test results, which need to be completed within 14 days before enrollment: ANC >= 1500 cells / µL, and did not receive granulocyte colony stimulating factor supportive therapy, lymphocyte With a count of >= 500 / µL, a platelet count of 100,000 / µL, and no blood transfusion, hemoglobin >= 9.0 g / dL, patients can achieve this standard through blood transfusion. INR or aPTT <= 1.5 x upper limit of normal value (ULN), this standard only applies to patients who are not currently receiving anticoagulation therapy; for patients who are currently receiving anticoagulation therapy, they should receive a stable dose of anticoagulant therapy. AST, ALT, and alkaline phosphatase <= 2.5 x ULN, except for the following cases: patients with confirmed liver metastasis: AST and / or ALT <= 5 x ULN, patients with confirmed liver metastasis or bone metastases: alkaline phosphatase <= 5 x UL Serum bilirubin <= 1.25 x ULN. Patients known to have Gilbert's disease are allowed serum bilirubin levels <= 3 x ULN. Serum creatinine <= 1.5 x ULN. 8. Subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. 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 fully retreated in childhood can be included without any intervention in adults; asthma that requires bronchodilators for medical intervention cannot be included); 2. Existence of active infections, such as: active hepatitis B (chronic or acute; defined as positive for detection of hepatitis B virus surface antigen [HBsAg] during the screening period) or patients with hepatitis C who have been cured by previous hepatitis B virus (HBV) infection or Patients (defined as hepatitis B core antibody [HBcAb] positive and HBsAg negative) may participate in this study. Results of HBV DNA testing in such patients must be obtained before enrollment. Among patients with positive HCV antibody, only patients with negative HCV RNA by polymerase chain reaction (PCR) can participate in this study; HIV test results are positive; active tuberculosis; 3. Severe cardiovascular disease, such as New York Heart Association heart disease (grade II or higher), myocardial infarction that occurred within 3 months before randomization, cerebrovascular accident, unstable arrhythmia, unstable angina pectoris Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction =140 mmHg or diastolic blood pressure >= 90 mmHg); 8. Patients with abnormal blood coagulation function and having bleeding tendency (must be satisfied 14 days before randomization: INR is within the normal range without using anticoagulants); use of anticoagulants or vitamin K antagonists such as warfarin, Patients treated with heparin or its analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (for a preventive use) is permitted on the premise that the internationally standardized ratio (INR) of prothrombin time Daily dosage does not exceed 100 mg); 9. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis (venous thrombosis caused by venous catheterization due to prior chemotherapy) within 6 months before screening Except those) and pulmonary embolism; 10. Multiple factors affecting oral medication (such as inability to swallow, chro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactLiyun Miao
Outcome results
None listed