This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC
This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion
According to the incidence of treatment-related adverse events(AEs)to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) therapy for multiple primary early-stage Non-Small Cell Lung Cancer (NSCLC)
Incidence of treatment-related adverse events(AEs)Description: Number and severity of adverse events graded according to CTCAE v5.0.
Time frame: up to three years
According to the subgroup analysis of TILs in patients with multiple primary early-stage NSCLC to analyze the correlation between TILs and disease prognosis
TILs subgroup analysis Description: Composition, phenotype, and function of TILs
Time frame: up to three months
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