{
  "abstract": "Introduction Cholangiocarcinoma (CCA) carries a high risk of recurrence even after curative resection. Capecitabine is standard adjuvant therapy, but recurrence rates remain significant, particularly in high-risk patients. Immunotherapy has shown promise in advanced CCA, prompting investigation into its role in earlier settings.Methods and analysis This multicentre, randomised, open-label phase II trial will compare adjuvant adebrelimab plus capecitabine versus capecitabine alone in patients with high-risk resected CCA. The study is being conducted at four tertiary hospitals in Jiangsu Province, China. Eligible patients will be randomised 1:1. The primary endpoint is 1-year recurrence-free survival rate (1y-RFS rate). Secondary endpoints are overall survival, RFS and safety. Exploratory endpoints are circulating tumour DNA (ctDNA)-based MRD assessment.Ethics and dissemination The study is approved by the Institutional Review Board of Jiangsu Provincial People’s Hospital (2024-SR571). Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration number NCT06607276.",
  "authors": [
    {
      "affiliations": [
        "Department of Oncology, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China"
      ],
      "name": "Yuan Cheng"
    },
    {
      "affiliations": [
        "Hepatobiliary Center, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China",
        "Key Laboratory of Liver Transplantation, Chinese Academy of Medical Sciences, NHC Key Laboratory of Living Donor Liver Transplantation (Nanjing Medical University), Nanjing, Jiangsu, China"
      ],
      "name": "Yaodong Zhang"
    },
    {
      "affiliations": [
        "Hepatobiliary Center, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China",
        "Key Laboratory of Liver Transplantation, Chinese Academy of Medical Sciences, NHC Key Laboratory of Living Donor Liver Transplantation (Nanjing Medical University), Nanjing, Jiangsu, China"
      ],
      "name": "Changxian Li"
    },
    {
      "affiliations": [
        "Hepatobiliary Center, The First Affiliated Hospital With Nanjing Medical University, Nanjing, Jiangsu, China",
        "Key Laboratory of Liver Transplantation, Chinese Academy of Medical Sciences, NHC Key Laboratory of Living Donor Liver Transplantation (Nanjing Medical University), Nanjing, Jiangsu, China"
      ],
      "name": "Xiangcheng Li"
    }
  ],
  "title": "Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial",
  "uid": "c2de7042-4006-5d69-9db8-8d5d7be1be30"
}