Small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. signed written informed consent before enrollment; 2. age > 18 years, both men and women; 3. pathological examination confirmed the diagnosis of small cell lung cancer, chemotherapy-based treatment is required; 4. Karnofsky performance status (KPS) = 50 points, expected survival = 3 months, follow-up observation for more than 3 months; 5. blood routine, liver and kidney function, myocardial enzymes and electrocardiogram showed no significant abnormalities. 6. Subjects voluntarily join this study, with good compliance and cooperation in safety and survival follow-up
Exclusion criteria
Exclusion criteria: 1. allergic to biological agents; 2. received any cytotoxic chemotherapy or PD-1/PD-L1 inhibitor treatment = 14 days before the first dose of study drug (if relevant); 3. received any study drug = 30 days or = half-life (whichever is longer) before the first dose of study drug; 4. had poor healing factors such as edema, ischemia, and tension at the anastomotic stoma; 5. complete intestinal obstruction; 6. severe cardiovascular disease; 7. infectious disease; 8. bleeding tendency or coagulation dysfunction; 9. unstable vital signs; 10. cachexia; 11. the investigator believes that it should be excluded from this study, such as the investigator 's judgment that the subject has other factors that may force the study to terminate halfway, such as other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, Or data and sample collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe neutropenia during treatment cycles;Incidence of agranulocytosis with fever during treatment cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| CD8 +/Treg ratio change;Objective response rate (0RR);Patients' quality of life (QoL);Safty; | — |
Countries
China
Contacts
Datong Second People 's Hospital (Cancer Hospital)