{
  "abstract": "Introduction: Small-cell lung cancer (SCLC) is an aggressive neuroendocrine malignancy with a poor overall prognosis. Surgery and concurrent chemoradiotherapy are currently recommended treatments for limited-stage SCLC (LS-SCLC), yet their efficacy remains limited. Recent advances have demonstrated the promising role of immunotherapy in LS-SCLC, reshaping the treatment paradigm. In parallel, neoadjuvant chemoimmunotherapy has become a standard of care for resectable non-small cell lung cancer. These provide a compelling rationale for exploring similar strategies in LS-SCLC to improve outcomes. We therefore conducted this study to evaluate the efficacy and safety of a novel neoadjuvant regimen incorporating adebrelimab, apatinib and chemotherapy in patients with LS-SCLC and to explore relevant biomarkers.\n\nMethods and analysis: This is a single-arm, multicentre, prospective, exploratory phase II trial. A total of 38 patients with untreated, resectable LS-SCLC will receive four cycles of neoadjuvant therapy: adebrelimab (1200 mg, every 3 weeks (q3w)), apatinib (250 mg every other day (qod), 3 times/week, q3w for three cycles), and chemotherapy (etoposide plus carboplatin, q3w). Surgery is scheduled 4–8 weeks after neoadjuvant treatment (with a 4-week apatinib washout), followed by adjuvant adebrelimab plus apatinib with or without radiotherapy based on multidisciplinary assessment. The primary endpoint is 2-year event-free survival rate. Secondary endpoints include pathological complete response, major pathological response, objective response rate, overall survival, event-free survival and safety. Exploratory biomarker analyses using tumour tissue and serial blood samples will employ spatial single-cell sequencing, proteomics and circulating tumour DNA for minimal residual disease monitoring. We also use the tumour microenvironment using high-resolution spatial transcriptomics to explore the changing dynamics of tumour in situ trying to obtain the mechanistic explanation for potential non-responders.\n\nEthics and dissemination: This study was approved by the Medical Ethics Committee of Zhejiang Cancer Hospital, on 3 May 2024 (approval number IRB-2024-420 (IIT)). The version of this study protocol is V.8.0, dated 16 December 2025. The patients have been enrolled since June 2024. All participants will provide written informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences.\n\nTrial registration number: NCT06483282.",
  "abstract_shown": true,
  "affiliations": [
    "Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, Zhejiang, China"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Ying Jin"
    },
    {
      "affs": [
        0
      ],
      "name": "Weishan Lu"
    },
    {
      "affs": [
        0
      ],
      "name": "Lishu Lou"
    },
    {
      "affs": [
        0
      ],
      "name": "Jian Zeng"
    },
    {
      "affs": [
        0
      ],
      "name": "Yun Fan"
    },
    {
      "affs": [
        0
      ],
      "name": "Da Chen",
      "orcid": "0009-0006-8320-0949"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/c241e83fz50s2.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-118036",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13711550/",
  "id": "c241e83fz50s2",
  "issns": [
    "2044-6055",
    "2044-6055"
  ],
  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118036",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "1506"
    ],
    [
      "heading",
      "1717"
    ],
    [
      "heading",
      "Oncology"
    ],
    [
      "heading",
      "Protocol"
    ],
    [
      "openalex",
      "2730|Lung Cancer Research Studies"
    ]
  ],
  "openalex": "W7223138502",
  "pdf_url": "https://bmjopen.bmj.com/content/bmjopen/16/10/e118036.full.pdf",
  "pmcid": "PMC13711550",
  "pmid": "42907122",
  "published": "2026-10-21",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/c241e83fz50s2.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:44Z",
      "native_id": "10.1136/bmjopen-2026-118036",
      "source": "crossref",
      "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118036"
    },
    {
      "first_seen": "2026-10-31T12:22:18Z",
      "native_id": "PMC13711550",
      "source": "pmc",
      "url": "https://doi.org/10.1136/bmjopen-2026-118036"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "heading:Oncology",
      "subfield": "oncology"
    }
  ],
  "title": "Adebrelimab combined with apatinib and chemotherapy for neoadjuvant therapy and biomarker analysis in limited-stage small cell lung cancer: study protocol for a single-arm trial",
  "title_text": "Adebrelimab combined with apatinib and chemotherapy for neoadjuvant therapy and biomarker analysis in limited-stage small cell lung cancer: study protocol for a single-arm trial",
  "type": "peer-reviewed",
  "updated_at": "2026-10-31T12:22:18Z",
  "url": "https://research.draconitic.com/paper/c241e83fz50s2",
  "venue": "BMJ Open",
  "versions": []
}