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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Tian Tian Tian, Master's degree
- Puhelinnumero: 13866195758
- Sähköposti: tiantian@ustc.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Pan yueyin Chief Medical Officer of Clinical Research, Doctoral degree
- Puhelinnumero: 13805695539
- Sähköposti: panyueyin@ustc.edu.cn
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pathological Complete Response (pCR) Rate
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Major Pathological Response (MPR) Rate
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Pan Yue Yin, Doctoral degree, Anhui Provincial Cancer Hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Antineoplastiset aineet, immunologiset
- Antineoplastiset aineet
- Farmakologisen vaikutuksen molekyylimekanismit
- Orgaaniset kemikaalit
- Farmakologiset vaikutukset
- Kemialliset vaikutukset ja käyttötarkoitukset
- Terapeuttinen käyttö
- Hiilivety
- Sykloparaffiinit
- Hiilivedyt, aliisykliset
- Hiilivedyt, sykliset
- Terpeenit
- Koordinointikompleksit
- Taksoidit
- Syklodekaanit
- Diterpeenit
- Immuunijärjestelmän tarkistuspisteen estäjät
- Karboplatiini
- Paklitakseli
- shenqi fuzheng
Muut tutkimustunnusnumerot
- 2026-LLYJ-0043
- 2026-LLYJ-0043 (Rekisterin tunniste: LZ-SFI-NSCLC-01)
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