lung cancer
Conditions
Interventions
Experimental group:Vinorelbine capsules +PD-1/PD-L1 inhibitor
Sponsors
The Seventh Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Lung squamous cell carcinoma was confirmed by histology or cytology. Stage IV was radiographically diagnosed (staging according to AJCC eighth edition). After 4 to 6 courses of first-line treatment with platinum-containing regimen, the tumor did not progress. 2. No gender limit; Aged between 18 and 75 years; ECOG score 0~2 points; The expected survival time is over 12 weeks. 3. Adequate bone marrow function and liver and kidney function should be assessed by the following laboratory requirements within 7 days prior to initiation of study therapy: (1) White blood cell >=3.0x10^9/L, absolute neutrophil count (ANC) >=1.5x10^9/L, platelet count >=80x10^9/L, hemoglobin (Hb) >=9g/dL. (2) Total bilirubin =40 mL/min. 4. Men and women of reproductive age must use contraception during the study period and for 24 weeks after the end of the study period. 5. Fully understand the study, voluntarily participate in the study and sign the informed consent in person; Subjects were able to communicate well with the investigator and complete the study in accordance with study regulations.
Exclusion criteria
Exclusion criteria: 1. The subject has dysphagia or inability to swallow pills; 2. Known allergy to any component of the investigational drug; 3. Autoimmune diseases; 4. Acquired immunosuppression; 5. Subjects with active hepatitis B and hepatitis C; 6. HIV-infected subjects; 7. Symptomatic heart disease, such as heart failure exceeding NYHA Level 2, unstable angina, myocardial infarction occurring within 24 weeks, clinically significant supracentricular or ventricular arrhythmias requiring treatment or intervention; 8. Pregnant or lactating subjects; 9. Concomitants that, in the investigator's judgment, seriously endanger the subject's safety or interfere with the subject's completion of the study; 10. The investigator evaluated subjects who were ineligible for the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactWang Bo
The Seventh Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed