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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tian Tian Tian, Master's degree
- Numéro de téléphone: 13866195758
- E-mail: tiantian@ustc.com
Sauvegarde des contacts de l'étude
- Nom: Pan yueyin Chief Medical Officer of Clinical Research, Doctoral degree
- Numéro de téléphone: 13805695539
- E-mail: panyueyin@ustc.edu.cn
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pathological Complete Response (pCR) Rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Major Pathological Response (MPR) Rate
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Pan Yue Yin, Doctoral degree, Anhui Provincial Cancer Hospital
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Agents antinéoplasiques immunologiques
- Agents antinéoplasiques
- Mécanismes moléculaires d'action pharmacologique
- Produits chimiques organiques
- Actions pharmacologiques
- Actions et utilisations chimiques
- Utilisations thérapeutiques
- Hydrocarbures
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Terpènes
- Complexes de coordination
- Taxes
- Cyclodécanes
- Diterpènes
- Inhibiteurs de point de contrôle immunitaire
- Carboplatine
- Paclitaxel
- shenqi fuzheng
Autres numéros d'identification d'étude
- 2026-LLYJ-0043
- 2026-LLYJ-0043 (Identificateur de registre: LZ-SFI-NSCLC-01)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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