Small cell lung cancer
Conditions
Interventions
one:After 4-6 cycles of treatment with Adebelizumab + bevacizumab + chemotherapy, maintenance therapy with Adebelizumab + bevacizumab
two:After 4-6 cycles of Adebelizumab + chemotherapy, Adebelizumab + bevacizumab was maintained.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Age 18-75 years old, gender unlimited 2: Diagnosis of extensive stage small cell lung cancer (ES-SCLC) confirmed by histopathology or cytology (according to American Veterans Lung Cancer Association, VALG staging) 3: Has not received treatment for ES-SCLC 4: At least one measurable lesion (according to RECIST 1.1 standards) 5: Patients with asymptomatic or stable brain metastases after treatment were admitted 6: ECOG PS is 0 or 1 7: Expected survival = 3 months 8: The functional level of the organ must meet the following requirements: ANC = 1.5×109/L; PLT = 90×109/L; Hb = 90 g/L; TBIL = 1×ULN; ALT and AST = 1.5×ULN, ALP = 2.5×ULN; BUN and Cr = 1× ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); LVEF = 50%; Fridericia Corrected QT Interval (QTcF) male < 450 ms, female < 470 ms; INR = 1.5 x ULN, ACTT = 1.5 x ULN. 9: The subjects signed informed consent and voluntarily joined the study
Exclusion criteria
Exclusion criteria: 1: Patients who had converted from non-small cell lung cancer (NSCLC) to SCLC or SCLC with mixed histological types were not eligible 2: Previous treatment for ES-SCLC 3: Patients who are allergic or hypersensitive to therapeutic drugs or have autoimmune diseases 4: Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites) 5: Use steroid therapy for more than 50 days, or long-term use of steroids is required 6: Uncontrolled symptomatic brain metastases or mental abnormalities that do not correctly represent subjective symptoms 7: Pregnant or lactating women who are fertile but refuse to take contraceptive measures 8: Patients with a history of severe heart disease, including a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, medically treatable angina pectoris, clinically clear valvular heart disease, a history of severe myocardial infarction, and intractable hypertension 9: Have received an allogeneic tissue/solid organ transplant 10: A concomitant medical condition that, in the investigator's judgment, seriously endangers the subject's safety or interferes with the subject's completion of the study (e.g., unclinically controlled hypertension, diabetes, thyroid disease, etc.) 11: The investigators determined that other conditions were not suitable for inclusion in the study, such as subjects at risk for hemoptysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Adverse medical events;Overall Survival;Objective response rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactGengyun Sun
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed