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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tian Tian Tian, Master's degree
- Número de teléfono: 13866195758
- Correo electrónico: tiantian@ustc.com
Copia de seguridad de contactos de estudio
- Nombre: Pan yueyin Chief Medical Officer of Clinical Research, Doctoral degree
- Número de teléfono: 13805695539
- Correo electrónico: panyueyin@ustc.edu.cn
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pathological Complete Response (pCR) Rate
Periodo de tiempo: Tumour tissue specimens were obtained at the time of surgery
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Major Pathological Response (MPR) Rate
Periodo de tiempo: From enrollment to surgery following neoadjuvant therapy.
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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.
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Recurrence-Free Survival (RFS)
Periodo de tiempo: From enrollment to 36 months post-treatment
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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
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Radiological Complete Response (rCR) Rate
Periodo de tiempo: From Enrollment to Surgery After Neoadjuvant Therapy
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pan Yue Yin, Doctoral degree, Anhui Provincial Cancer Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Agentes antineoplásicos inmunológicos
- Agentes antineoplásicos
- Mecanismos moleculares de acción farmacológica.
- Químicos orgánicos
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Hidrocarburos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Terpenos
- Complejos de coordinación
- Taxaides
- Ciclodecanos
- Diterpenos
- Inhibidores de puntos de control inmunitarios
- Carboplatino
- Paclitaxel
- shenqi fuzheng
Otros números de identificación del estudio
- 2026-LLYJ-0043
- 2026-LLYJ-0043 (Identificador de registro: LZ-SFI-NSCLC-01)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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