Lung cancer
Conditions
Interventions
exposure group (Defined as an increase in CTC PD-L1 counts from T0 to T3):PD-1/PDL1 mab combined with conventional chemotherapy
non-exposure group (Defined as a decrease or no change in CTC PD-L1 counts from T0 to T3):PD-1/PDL1 mab combined with conventional chemotherapy
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age >18 years; (2) Gender unspecified; (3) ECOG performance status score =2; (4) Histologically confirmed locally advanced or recurrent (Stage IIIb, not suitable for surgery) or metastatic (Stage IV) lung cancer, including small cell or non-small cell carcinoma; (5) Intended first-line treatment with a standard PD1/PD-L1 monoclonal antibody in combination with chemotherapy for a minimum of 4 cycles, with the specific chemotherapy regimen determined by the investigator based on the patient's pathological characteristics and physiological function; (6) Life expectancy exceeding 12 weeks; (7) At least one measurable lesion based on RECIST 1.1 solid tumor efficacy assessment criteria; (8) Organ function levels must meet the following requirements: ? Hematological parameters: Absolute neutrophil count =1.5×10^9/L, platelet count =80×10^9/L, hemoglobin =90 g/L; ? Liver function: Total bilirubin =1.5 times the upper limit of normal, alanine transaminase, and aspartate transaminase =2.5 times the upper limit of normal, and, in the case of liver metastasis, transaminases =5.0 times the upper limit of normal; ? Renal function: Creatinine =1.25 times the upper limit of normal, and creatinine clearance rate =60 ml/min; ? Coagulation function: INR, PT, and APTT =1.5 times the upper limit of normal; ? Essentially normal electrocardiogram. (9) Patients must provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Pregnancy or lactation; (2) Individuals with a known human immunodeficiency virus (HIV) infection or a history of organ transplantation; (3) Severe uncontrolled underlying conditions, including severe cardiopulmonary insufficiency, uncontrolled infections, or bleeding; (4) Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids, immunosuppressants); Replacement therapies (such as thyroid hormones, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered as systemic treatment; (5) Patients who have received 2 or more different immune checkpoint inhibitors (ICI) during treatment; (6) Patients with severe liver or kidney impairment, heart failure, or severe anemia prior to ICI initiation; (7) Poor treatment adherence or incomplete patient medical records; (8) Patients deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of progression-free survival between the exposure group and the non-exposure group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of object rate and overall survival between the exposure group and the non-exposure group;Analyzing the changes in CTC PD-L1 counts at T0, T1, T2, T3, and Tn (at the time of disease progression);Comparing the clinical outcomes between the high-level and low-level groups of CTC PD-L1 counts at T0, T2, and T3, including ORR (overall response rate), PFS (progression-free survival), and OS (overall survival).; | — |
Countries
China
Contacts
Public ContactZhihui Wang
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed