Clinical Trial

Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies

Not Yet Recruiting Phase 2
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Record status
This record was last updated May 28, 2025 (before its estimated April 25, 2026 completion). Its status may not reflect the trial's current state.
Summary
This Phase II, single-arm, single-center study evaluates the conversion to resectability and safety of Ivonescimab combined with liposomal irinotecan and 5-FU/LV in patients with potentially resectable biliary tract malignancies. Eligible patients receive three cycles of the combination therapy every 3 weeks, followed by surgery. Post-surgery, patients resume treatment for three more cycles and then continue with evoracizumab alone for up to 1 year. Safety is monitored through AE and SAE assessments for at least 30 and 90 days post-last dose, respectively. Biomarker exploration is also conducted in consenting patients.
Trial Details
NCT Number NCT06993025
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Biliary Tract Cancer
Enrollment 30 participants
Start Date 2025-05-25
Primary Completion 2026-04-25 (estimated)
Study Completion 2027-04-25 (estimated)
Updated on ClinicalTrials.gov 2025-05-28