A Prospective Trial of SFI Plus PD-1 Inhibitors and PBC in Resectable NSCLC (SFI-NSCLC) (SFI-NSCLC)
A Prospective Trial Evaluating the Efficacy and Tumor Immune Microenvironment Remodeling Induced by Shenqi Fuzheng Injection Combined With Neoadjuvant PD-1 Inhibitors and Platinum-Based Chemotherapy in Resectable Locally Advanced NSCLC
This prospective, single-center clinical trial will enroll 30 treatment-naïve patients with locally advanced, resectable stage II-IIIA non-small cell lung cancer (NSCLC) to receive neoadjuvant Shenqi Fuzheng Injection (SFI) in combination with a PD-1 inhibitor and platinum-based chemotherapy. The primary endpoint is the pathological complete response (pCR) rate, while secondary endpoints include the major pathological response (MPR) rate and event-free survival (EFS). Furthermore, single-cell and spatial transcriptomics will be employed to dynamically track alterations in the immune regulatory network within the tumor microenvironment (TME) pre- and post-SFI administration. This approach aims to elucidate how SFI remodels the TME immune landscape and to uncover its potential advantages in improving clinical outcomes. Additionally, we will investigate the synergistic effects of SFI combined with PD-1 blockade and platinum-based chemotherapy, with the ultimate goal of advancing the integration of traditional Chinese medicine into the therapeutic paradigm for resectable NSCLC.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study plans to enroll 30 treatment-naïve patients with locally advanced, resectable non-small cell lung cancer (NSCLC). Enrolled patients will receive 2 to 3 cycles of neoadjuvant combination therapy, including Shenqi Fuzheng Injection (SFI), a PD-1 inhibitor, and platinum-based chemotherapy, followed by surgical resection 3 to 4 weeks after completion of treatment. The primary outcome measure is the pathological response rate of the tumor following surgery. Additionally, advanced genomic profiling techniques will be employed to analyze changes in the tumor immune microenvironment before and after treatment, with the aim of elucidating the underlying mechanisms of action of SFI.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Tian Tian Tian, Master's degree
- Номер телефона: 13866195758
- Электронная почта: tiantian@ustc.com
Учебное резервное копирование контактов
- Имя: Pan yueyin Chief Medical Officer of Clinical Research, Doctoral degree
- Номер телефона: 13805695539
- Электронная почта: panyueyin@ustc.edu.cn
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Aged 18 to 75 years, with a pathologically confirmed diagnosis of resectable stage IB (tumor diameter ≥4 cm), IIA or IIIA (AJCC 8th edition) NSCLC.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with an estimated life expectancy ≥3 months.
No prior history of immunotherapy or platinum-based chemotherapy. No known EGFR mutations or ALK rearrangements. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Adequate bone marrow reserve and vital organ function (ANC ≥1.5 × 10⁹/L, PLT ≥75 × 10⁹/L, Hb ≥90 g/L; hepatic and renal function parameters within 1.5 × ULN).
Voluntary participation and provision of written informed consent. Subjects of childbearing potential must agree to use effective contraceptive measures for at least 90 days after the last dose.
Exclusion Criteria:
- Pregnant and/or lactating women; Women of childbearing potential with a positive serum pregnancy test; Unresectable or metastatic disease: tumor invasion into critical structures (e.g., vertebral body, carina, or heart) or tumor metastases, including M1 stage and brain metastases (unless neurologically asymptomatic and radiologically stable for ≥4 weeks following prior therapy); Severe comorbidities, including interstitial lung disease (ILD), defined as a documented history of or active ILD, and autoimmune diseases (e.g., systemic lupus erythematosus and rheumatoid arthritis) requiring systemic immunosuppressive therapy.
History of neurological or psychiatric disorders. Uncontrolled infections, uncontrolled hypertension, or severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems.
History of solid organ transplantation or chronic use of immunosuppressive therapy (including topical or local administration) Known hypersensitivity to Shenqi Fuzheng Injection or its excipients, or a history of allergic diathesis or multiple drug allergies.
Concurrent malignancy or a history of any other malignancy diagnosed within 5 years prior to randomization, except for adequately treated localized cancers (e.g., carcinoma in situ of the cervix, basal cell carcinoma, cutaneous squamous cell carcinoma, or papillary thyroid carcinoma).
Patients deemed unsuitable for study participation at the investigator's discretion or those who voluntarily withdraw consent prior to enrollment.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: SFI plus PD-1 and PBC
Patients received neoadjuvant Shenqi Fuzheng Injection (SFI; 250 mL intravenous infusion once daily for 10 consecutive days) in combination with a PD-1 inhibitor and platinum-based doublet chemotherapy. SFI administration commenced 2 days prior to the initiation of cycle 3 chemotherapy. Surgical resection was performed 3-4 weeks after completion of neoadjuvant therapy. |
Shenqi Fuzheng Injection (SFI) in combination with anti-PD-1 monoclonal antibody plus platinum-based doublet chemotherapy as neoadjuvant therapy. SFI is administered starting 3 days before the third cycle of chemotherapy, given by intravenous infusion at a dose of 250 mL once daily for 10 consecutive days.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pathological Complete Response (pCR) Rate
Временное ограничение: Tumour tissue specimens were obtained at the time of surgery
|
Defined as the proportion of randomized subjects with no residual viable tumor in the lung and sampled lymph nodes, as assessed by a Blinded Independent Pathological Review (BIPR), divided by the total number of randomized subjects in the respective treatment group. |
Tumour tissue specimens were obtained at the time of surgery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Major Pathological Response (MPR) Rate
Временное ограничение: From enrollment to surgery following neoadjuvant therapy.
|
Defined as the proportion of randomized subjects with ≤10% residual viable tumor in the lung and sampled lymph nodes, as assessed by BIPR, divided by the total number of subjects in the respective treatment group. |
From enrollment to surgery following neoadjuvant therapy.
|
|
Recurrence-Free Survival (RFS)
Временное ограничение: From enrollment to 36 months post-treatment
|
Defined as the time interval from the date of surgery to the date of documented disease recurrence or the date of the last follow-up, whichever occurs first. |
From enrollment to 36 months post-treatment
|
|
Radiological Complete Response (rCR) Rate
Временное ограничение: From Enrollment to Surgery After Neoadjuvant Therapy
|
Defined as the absence of contrast enhancement in the original tumor bed as demonstrated by contrast-enhanced mediastinal MRI. The rCR will be dynamically monitored at three timepoints: prior to neoadjuvant therapy, before the initiation of Cycle 3 of the immuno-chemotherapy regimen (i.e., prior to Shenqi Fuzheng Injection administration), and prior to surgical resection. |
From Enrollment to Surgery After Neoadjuvant Therapy
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Pan Yue Yin, Doctoral degree, Anhui Provincial Cancer Hospital
Публикации и полезные ссылки
Общие публикации
- Yu H, Zhu W, Lin C, Jia M, Tan X, Yuan Z, Feng S, Yan P. Stromal and tumor immune microenvironment reprogramming through multifunctional cisplatin-based liposomes boosts the efficacy of anti-PD-1 immunotherapy in pancreatic cancer. Biomater Sci. 2023 Dec 19;12(1):116-133. doi: 10.1039/d3bm01118f.
- Suzuki R, Watanabe S, Shono K, Masuda T, Yanai K, Yamazaki R, Ando Y, Wakabayashi T, Tanaka S, Sekiya T, Kushiro K, Yanagimura N, Sato M, Tanaka T, Nozaki K, Saida Y, Hokari S, Arita M, Ohashi R, Shima K, Kimura Y, Aoki N, Ohshima Y, Koya T, Kikuchi T. Nintedanib enhances the antitumor efficacy of pd-1 blockade, potentially through inhibition of myeloid-derived suppressor cells and cancer-associated fibroblasts. Cancer Immunol Immunother. 2026 Mar 5;75(4):94. doi: 10.1007/s00262-026-04350-x.
- Dong J, Su SY, Wang MY, Zhan Z. Shenqi fuzheng, an injection concocted from Chinese medicinal herbs, combined with platinum-based chemotherapy for advanced non-small cell lung cancer: a systematic review. J Exp Clin Cancer Res. 2010 Oct 22;29(1):137. doi: 10.1186/1756-9966-29-137.
- Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, Postmus PE, Rusch V, Sobin L; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):706-14. doi: 10.1097/JTO.0b013e31812f3c1a.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Противоопухолевые агенты, иммунологические
- Противоопухолевые агенты
- Молекулярные механизмы фармакологического действия
- Органические химические вещества
- Фармакологические действия
- Химические действия и используют
- Терапевтическое использование
- Углеводороды
- Циклопарафины
- Углеводороды, алициклический
- Углеводороды, циклические
- Терпена
- Координационные комплексы
- Таксииды
- Циклодеканы
- Diterpenes
- Ингибиторы иммунных контрольных точек
- Карбоплатин
- Паклитаксел
- shenqi fuzheng
Другие идентификационные номера исследования
- 2026-LLYJ-0043
- 2026-LLYJ-0043 (Идентификатор реестра: LZ-SFI-NSCLC-01)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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