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.
Keywords: ADJUVANT TREATMENT; CHOLANGIOCARCINOMA; GASTROINTESTINAL CANCER.
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