What this Trial Is About

Researchers are studying biliary tract malignancies, which are cancers originating from the bile duct lining. Surgery is the main treatment, but many patients still experience tumor recurrence after surgery, which lowers survival rates. Current adjuvant treatments like capecitabine are recommended but still face high recurrence rates, especially in high-risk patients. This study aims to explore whether adding Adebrelimab to capecitabine as postoperative adjuvant therapy can improve outcomes and reduce tumor recurrence in these patients. Participants will be randomly assigned to receive either Adebrelimab combined with capecitabine or capecitabine alone after surgery. Adebrelimab will be given intravenously at 1200 mg every three weeks for one year, while capecitabine will be taken orally twice daily on days 1 to 14 of a 21-day cycle for 6 to 8 cycles. The study is open-label and conducted across multiple centers to compare the safety and effectiveness of these treatments in patients with high-risk cholangiocarcinoma following surgery. During the study, participants will be closely monitored with imaging and laboratory tests to check for cancer recurrence and assess safety. Researchers will measure the one-year recurrence-free survival rate as the primary outcome. Other evaluations will include regular blood tests and clinical assessments. The total duration of treatment and follow-up will last about one year, with ongoing safety checks to track any side effects and overall patient health throughout the trial.

Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE