small cell lung cancer
Conditions
Interventions
treatment group:Chemotherapy combined with immunotherapy followed by thoracic radiotherapy for 4-6 cycles, then maintenance therapy with immunotherapy combined with anlotinib
Control group:Chemotherapy combined with immunotherapy followed by thoracic radiotherapy for 4-6 cycles, then maintenance therapy with immunotherapy monotherapy
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subjects voluntarily signed the informed consent and were willing to return to the hospital for follow-up, and the compliance was good; (2)Patients aged >=18 years and = 1.5×10?/L,Platelet count (PLT) >= 100×10?/L,Hemoglobin (Hb) >= 90g/L b) international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT) =25 g/L (2.5 g/dL) f) serum creatinine (Cr) = 60mL/min g) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%.
Exclusion criteria
Exclusion criteria: (1)Treatment with systemic immunostimulants (including but not limited to interferons, interleukin-2, tumor necrosis factor) within 4 weeks prior to the first dose of the investigational drug or within 5 half-lives of the drug (whichever is longer) (cancer vaccines allowed if prior) (2)Treatment with any Chinese herbal medicine for cancer control within 14 days prior to the first dose of the investigational drug (3) Any disease requiring corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppre-ssants within 14 days prior to the first dose of the investigational drug, except: Replacement therapy (=500 IU/mL (2500 copies/mL), as well as patients with active hepatitis C (HCV): Inactive HBsAg carriers,Patients with controlled HBV infection on antiviral therapy (HBV DNA <500 IU/mL) (14) History of Human Immunodeficiency Virus (HIV) infection (15) Any of the following cardiovascular risk factors: a) Cardiac chest pain <=28 days prior to the enrollment, defined as moderate pain limiting instrumental activities of daily living b) Symptomatic pulmonary embolism <=28 days before the first administration c) History of acute myocardial infarction <=6 months before the first administration d) History of Class III or IV heart failure <=6 months prior to the first dose of the investigational drug according to New York Heart Association (NYHA) e) Grade =2 ventricular arrhythmia <=6 months before the first administration f) History of cerebrovascular accident <=6 months prior to the first dose of the investigational
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median progression-free survival (mPFS);3-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| median overall survival (mOS);1/2/3-year PFS rate;Objective Response Rate;Duration of Responses;Disease Control Rate;Treatment Emergent Adverse Events;The value of circulating tumor cells (CTCs) in predicting treatment efficacy; | — |
Countries
China
Contacts
Public ContactMa Jinbo
Yantai Yuhuangding Hospital
Outcome results
None listed