The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.
This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection. The study will enroll patients with ECC who have not received prior systemic therapy. The primary endpoint is the 2-year recurrence-free survival rate (2y-RFS), with a planned enrollment of approximately 65 subjects. After providing full informed consent, eligible patients will receive treatment with tislelizumab injection combined with capecitabine and radiotherapy. Each study treatment cycle is 3 weeks, and treatment will continue until the criteria for terminating study treatment are met. Treatment regimen for the treatment group: 1. Tislelizumab injection: 200 mg via intravenous infusion (D1), administered every 21 days (Q3W), with maintenance treatment for at least half a year or until disease progression. 2. Capecitabine: 1000 mg/m², twice daily (D1-14), administered every 21 days (Q3W) for a total of 6 treatment cycles. 3. Radiotherapy: 50Gy to regional lymph nodes and preoperative tumor bed.
Study Type
OBSERVATIONAL
Enrollment
10
The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.
Department of Hepatobiliary Surgery, the First Affiliated Hospital of Air Force Military Medical University
XiAn, Shanxi, China
2-year recurrence-free survival rate
The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the recurrence-free survival status of patients will be observed at 2 years.
Time frame: 2 Year
2-year overall survival rate
The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the overall survival status of patients will be observed at 2 years.
Time frame: 2 Year
Incidence of adverse events
Time frame: 2 Year
Completion rate of treatment
Time frame: 2 Year
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