Solid tumors
Conditions
Interventions
Responder:Risk factors and radiomic features associated with response to immunotherapy combined with chemotherapy in non-small cell lung cancer
Non-Responder:Risk factors and radiomic features associated with non-response to immunotherapy combined with chemotherapy in non-small cell lung cancer
Sponsors
Wuxi people’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.This study will enroll patients diagnosed with non-small cell lung cancer (NSCLC) by histopathology or cytology, with a clinical stage of III or IV, representing advanced cases that are not eligible for surgical resection or radical radiotherapy. 2.Regarding treatment regimens, patients must have received combination chemotherapy based on immune checkpoint inhibitors (PD-1/PD-L1 antibodies) as first-line or subsequent therapy. 3.The integrity of imaging data is a core inclusion criterion. Patients must have complete serial CT images, including baseline before treatment (T0), after 3 treatment cycles (T1), and after 5 treatment cycles (T2). The slice thickness of CT images must be <=1 mm to meet the precision requirements for radiomic feature extraction. 4.In addition, according to RECIST 1.1 criteria, patients must have at least one measurable target lesion, complete clinical baseline data (including age, gender, smoking history, ECOG performance status), and key molecular pathological data (such as EGFR/ALK gene mutation status, PD-L1 expression level;
Exclusion criteria
Exclusion criteria: 1.Patients with poor CT image quality characterized by severe respiratory motion artifacts, cardiac motion artifacts, or metallic implant artifacts that preclude accurate segmentation of the tumor and peritumoral regions or fail to meet data analysis requirements will be excluded from the study. 2.Patients with a history of other malignancies will be excluded. 3.Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency, or other serious complications that result in intolerance to immunotherapy or an extremely short life expectancy (which would affect survival evaluation), will also be excluded. 4.Patients who received radiotherapy to the target lesion area before baseline imaging acquisition will also be excluded to avoid interference with imaging features.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Model prediction accuracy (Area Under the Curve,AUC / Sensitivity); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Objective Response Rate ORR;Dynamic Heterogeneity Index; | — |
Countries
China
Contacts
Public ContactXiaoyun Hu
Wuxi people’s Hospital
Outcome results
None listed