Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: A Multi - Omics Perspective

Официальное название

Construction of a Efficacy Stratification Prognostic and Prediction Model for Perioperative Immunotherapy in Non - Small Cell Lung Cancer Based on Multi - Omics Biomarkers

Обзор

This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.

Первичные конечные точки

• Pathological response after immune neoadjuvant therapy [Срок оценки: From enrollment to surgery at 18 weeks]

Вторичные конечные точки (2)

• 2-year Progression-Free Survival(PFS1) [Срок оценки: PFS of patients from the time of enrollment until two years]
• 2-year Progression-Free Survival(PFS2) [Срок оценки: PFS from the start of adjuvant immunotherapy to 2 years.]

Критерии участия

Критерии включения

• NSCLC, clinical tumor stage II-IIIB
• Without EGFR/ALK gene mutation
• Patient 18 years or older.
• Scheduled for neoadjuvant immunotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
• Life expectancy ≥ 12 weeks.
• Patient able to understand and sign written informed consent.

Критерии исключения

• With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
• With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.
• with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Xu J, Wan R, Cai Y, Cai S, Wu L, Li B, Duan J, Cheng Y, Li X, Wang X, Han L, Wu X, Fan Y, Yu Y, Lv D, Shi J, Huang J, Zhou S, Han B, Sun G, Guo Q, Ji Y, Zhu X, Hu S, Zhang W, Wang Q, Jia Y, Wang Z, Song Y, Wu J, Shi M, Li X, Han Z, Liu Y, Yu Z, Liu AW, Wang X, Zhou C, Zhong D, Miao L, Zhang Z, Zhao H, Yang J, Wang D, Wang Y, Li Q, Zhang X, Ji M, Yang Z, Cui J, Gao B, Wang B, Liu H, Nie L, He M, Ji PMID 39255777
• Ai X, Jia B, He Z, Zhang J, Zhuo M, Zhao J, Wang Z, Zhang J, Fan Z, Zhang X, Li C, Jin F, Li Z, Ma X, Tang H, Yan X, Li W, Xiong Y, Yin H, Chen R, Lu S. Noninvasive early identification of durable clinical benefit from immune checkpoint inhibition: a prospective multicenter study (NCT04566432). Signal Transduct Target Ther. 2024 Dec 16;9(1):350. doi: 10.1038/s41392-024-02060-3. PMID 39676097

Идентификаторы

NCT: NCT06856798 · IS25015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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