small cell lung cancer
Conditions
Interventions
Single arm:Anlotinib plus penpulimab and chemotherapy
Sponsors
The Third People's Hospital of Zhengzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~75 years old; 2. Extensive stage small cell lung cancer confirmed by histology or cytology; 3. No previous systematic treatment for extensive stage small cell lung cancer 4.ECOG score: 0-2; 5. Predicted survival >= 3 months; 6. Measurable lesions (according to RECIST 1.1 criteria, the CT scan diameter of tumor lesions is >= 10mm, the CT scan diameter of lymph node lesions is >= 15mm, the scan thickness is not more than 5mm, and the lesions can be measured without local treatment such as radiotherapy or freezing); 7. Normal function of major organs means that the following criteria are met: (1) The standard of blood routine examination should be met (no blood transfusion or blood products, no G-CSF or other hematopoietic stimulating factors were used for correction within 14 days) :A. Hemoglobin (HB) >= 90 g/L; B. Neutrophil absolute value (ANC) >= 1.5×109/L; C. Platelet (PLT) >= 80×109/L; (2) Biochemical tests shall meet the following standards: A. Total bilirubin (TBIL) & LT; 1.5 ULN; B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) & LT; 2.5ULN, and & LT for patients with liver metastases; 5 uln; C. Serum creatinine (Cr) <=1.25ULN or endogenous creatinine clearance & GT; 50 ml/min (Cockcroft-Gault formula); 8. Women of reproductive age must have used reliable contraception or had a pregnancy test (serum or urine) with negative results within 7 days before enrollment and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug. For men, consent to use appropriate methods of contraception or have been surgically sterilized during the trial period and for 8 weeks after the last administration of the trial drug; 9. The subjects volunteered to join the study and signed the informed consent. They had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or complete remission of asthma in childhood without any intervention as adults were included; Subjects with asthma requiring medical intervention with bronchodilators were excluded); 2. The presence of active infections, such as active hepatitis B (chronic or acute; Patients who were previously infected with or cured of hepatitis B virus (HBV) infection (defined as HBcAb positive and HBsAg negative) or hepatitis C during the screening period were eligible for participation. Before enrollment, HBV DNA test results must be obtained from such patients. Among patients who were antibody positive for hepatitis C virus (HCV), only those who were negative for HCV RNA by polymerase chain reaction (PCR) were eligible for participation; Test positive for HIV; Active pulmonary tuberculosis; (3) with severe cardiovascular disease, heart disease, such as New York heart association (class II or higher), randomly assigned three months before the occurrence of myocardial infarction, cerebrovascular accident, instability, unstable angina, arrhythmia, with known coronary artery disease, do not accord with standard of the congestive heart failure, or left ventricular ejection fraction & lt; 50% of patients must be treated with a stable regimen that the treating physician considers optimal, with consultation with a cardiologist if necessary; 4. Active or untreated CNS metastases and/or cancerous meningitis detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and prior imaging evaluation; 5. Patients with a history of idiopathic pulmonary fibrosis, organized pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening and a history of radiation pneumonitis (fibrosis) in the radiation area were eligible to participate in this study; 6. Patients requiring long-term systemic corticosteroid use. Patients with COPD or asthma requiring intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections were enrolled. 7. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; 8. Severe allergic reaction or allergic reaction to chimeric or humanized antibodies or fusion proteins or allergic reaction to etoposide/platinum in patients with definite history of drug allergy or allergic constitution; 9. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred in the 6 months prior to enrollment. A history of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism in the 3 months prior to enrollment (implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism); 10. Imaging shows that the tumor has invaded the periphery of important blood vessels or is judged by the investigator to be highly likely to invade important blood vessels and cause fatal massive bleeding during treatment; 11. Patients with hypertension that is not well controlled by antihypertensive medicati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DCR;Security; | — |
Countries
China
Contacts
Public ContactTiandong Kong
The Third People's Hospital of Zhengzhou
Outcome results
None listed