{
  "abstract": "Purpose: This study evaluated the antitumor activity and safety of cadonilimab, a programmed cell death protein 1 (PD-1)/cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) bispecific antibody, combined with platinum/carboplatin and 5-fluorouracil (PF) chemotherapy as first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).\n\nMethods: In this prospective, single-arm, phase II trial, patients with histopathologically confirmed R/M HNSCC received cadonilimab (10 mg/kg) plus PF chemotherapy every 3 weeks for 4–6 cycles, followed by maintenance cadonilimab. The primary endpoint was 1-year progression-free survival (PFS). A target sample size of 30 was planned, but the study was terminated prematurely after enrolling 16 patients due to slow accrual.\n\nResults: Sixteen patients were enrolled. At a median follow-up of 18.4 months (range, 4.6 - 39.6), the 1-year PFS and overall survival (OS) rates were 50.0% (95% CI: 30.6% - 81.6%) and 75.0% (95% CI: 56.5% - 99.5%), respectively. The Objective Response Rate (ORR) was 56.3% (95% CI: 29.9% - 80.2%). Median PFS and OS were 9.8 months (95% CI: 2.8 - NR) and 17.7 months (95% CI: 12.3 - NR), respectively. Grade ≥3 treatment-related adverse events (TRAEs) occurred in four patients (25%), with no treatment-related deaths or immune-related cardiac toxicities reported.\n\nConclusion: In this exploratory study, first-line cadonilimab combined with PF chemotherapy exhibited potential antitumor activity and manageable safety profiles in patients with R/M HNSCC. Given the favorable baseline profile of the cohort and the single-arm design, these findings should be interpreted with caution. Larger randomized controlled trials are required to determine whether dual PD-1/CTLA-4 blockade offers an incremental benefit over standard anti-PD-1-based regimens.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Radiation Oncology, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Clinical Research Center for Cancer Sichuan Cancer Center, Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China",
    "School of Medicine, University of Electronic Science and Technology of China"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 6,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Wenjun Liao"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Qiaohua Li"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Yue Deng"
    },
    {
      "affs": [
        0
      ],
      "name": "Jun Zhang"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Yue Zhao"
    },
    {
      "affs": [
        0,
        1
      ],
      "name": "Shichuan Zhang"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/f7nrr5xj20xbe.bib",
  "cited_by": 0,
  "doi": "10.3389/fonc.2026.1961360",
  "fulltext_url": null,
  "id": "f7nrr5xj20xbe",
  "issns": [
    "2234-943X"
  ],
  "landing_url": "https://www.frontiersin.org/articles/10.3389/fonc.2026.1961360/full",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2733|Head and Neck Cancer Studies"
    ]
  ],
  "openalex": "W7223172890",
  "pdf_url": "https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2026.1961360/pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-22",
  "publisher": "Frontiers Media SA",
  "ris": "https://research.draconitic.com/paper/f7nrr5xj20xbe.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:13Z",
      "native_id": "10.3389/fonc.2026.1961360",
      "source": "crossref",
      "url": "https://www.frontiersin.org/articles/10.3389/fonc.2026.1961360/full"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "issn:2234-943X",
      "subfield": "oncology"
    }
  ],
  "title": "PF chemotherapy combined with a PD-1/CTLA-4 bispecific antibody as first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma: a prospective, single-arm, phase II clinical study",
  "title_text": "PF chemotherapy combined with a PD-1/CTLA-4 bispecific antibody as first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma: a prospective, single-arm, phase II clinical study",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:13Z",
  "url": "https://research.draconitic.com/paper/f7nrr5xj20xbe",
  "venue": "Frontiers in Oncology",
  "versions": []
}