D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC
This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. 70 subjects will be enrolled in this prospective observation aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and carelizumab in patients with resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The treatment group regimen will be 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and carelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-containing two-agent chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.
⁃ Only patients who met all the following criteria were eligible for inclusion in the study:
⁃ Provide written informed consent Male or female, aged 18-75 years Eastern Cooperative Oncology Group performance status ≤1 Measurable lesions in accordance with RECIST, version 1.1 Subjects must be able to provide a specimen containing tumor tissue or have a biopsy sample of newly resected tumor tissue available PD-L1 IHC testing was performed at a central laboratory during the screening phase
• Before treatment, formalin-fixed, paraffin-embedded (FFPE) tissue blocks or non-stained tumor tissue sections and relevant pathology reports must be submitted for biomarker assessment. Tumor-tissue specimens could be fresh or archived within 6 months before enrollment.
• The tissue must be core needle biopsy section, excisional biopsy section or open biopsy section;
• It is recommended that fresh paraffin sections (PD-L1 assays be performed within 7 days of sectioning) slides be stored and transported in the dark
• It is recommended that fresh tissue be fixed in 10% neutral buffered formalin for 24 to 48 hours The patient's lung function or other organ function was evaluated by the surgeon to tolerate local surgical treatment.
⁃ Adequate organ function assessment and laboratory screening should be performed within 7 days of initiation of therapy
⁃ Reproductive status:
• A negative pregnancy test (serum or urine) in a woman of childbearing age within 72 hours before the start of treatment
• women were non-lactating
• For female patients, appropriate contraception should be used during treatment and for 6 months after the last dose of treatment (i.e., the time required for the 30-day ovulation cycle + the 5 half-lives of the drug).
• Male subjects must agree to use appropriate contraception during treatment and for 7 months after the last dose of treatment (i.e., the duration of 90-day sperm turnover + 5 half-lives of the drug).
⁃ And male subjects had to be willing to avoid donating sperm during this period.
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