Adjuvant sintilimab plus capecitabine in resected extrahepatic cholangiocarcinoma: Interim report of a single-arm, prospective phase II study.

作者：Jinxue Zhou, Zhengzheng Wang, Beilin Zhang, Qingjun Li, Li Wang, Baishun Wan, X. L. Wang, Tao He, Hong Cui · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco.2026.44.2_suppl.557 · 研究领域：Cholangiocarcinoma and Gallbladder Cancer Studies、Gastric Cancer Management and Outcomes、Gallbladder and Bile Duct Disorders

557 Background: The efficacy of adjuvant chemotherapy alone in extrahepatic cholangiocarcinoma (EHC) remains limited, with high recurrence rates after resection. This phase II study aimed to assess the safety and efficacy of sintilimab, an anti-PD-1 antibody, in combination with capecitabine as adjuvant therapy for patients with resected ECC. Methods: Eligible patients were aged 18 to 75 years, had histologically confirmed primary EHC, underwent R0 (no local residual tumor) or R1 (microscopic residual tumor) resection and an ECOG performance status score of 0 or 1. Participants received sintilimab (200 mg IV Q3W for 6 cycles) plus capecitabine (1250 mg/m² orally twice daily, days 1–14, Q3W for 8 cycles). The primary endpoint was 2-year recurrence-free survival (RFS). Secondary endpoints included 1-year RFS, 2- and 3-year overall survival (OS), and safety. ClinicalTrials.gov identifier: NCT05207735. Results: As of June 2025, 31 patients were enrolled and received at least one treatment cycle; 23 completed full treatment. Of 31 included patients, 12 (38.7%) were female, and the median age was 62.5 years. Most patients (26 of 31 [83.9%]) received R0 resection. With a median follow-up of 20.0 months (range:5.8-51.8), the 2-year RFS was 72.8%. The 2-year and 3-year OS rates were 75.5% and 68%, respectively. Further, treatment-related adverse events (TRAEs) of any grade occurred in 74.2% of patients, including anorexia (41.9%), fatigue (25.8%), nausea/vomiting (22.6%), hand-foot sy...