This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.
This study plans to recruit 30 patients with borderline resectable, locally advanced biliary tract cancer who have not received treatment, abserve and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
R0 resection rate
Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.
Time frame: up to 24 months
Surgery conversion rate
Proportion of patients who can undergo surgical resection among all enrolled patients
Time frame: up to 24 months
Objective response rate
The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum time limit, which is the sum of the proportions of complete remission and partial remission.
Time frame: up to 24 months
pathological complete response rate
After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0)
Time frame: up to 24 months
Major pathological response rate
After preoperative treatment and surgery, the proportion of residual viable tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10% (%RVT≤10)\*
Time frame: up to 24 months
Recurrence-free survival
Duration from surgical resection to first recurrence or death from any cause
Time frame: up to 24 months
Overall survival
Overall survival is measured from the first dose of study drug until death from any cause.
Time frame: up to 24 months
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AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months