NCT06993025

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

A Phase II, Open-Label, Single-Arm, Single-Center Study of Ivonescimab in Combination With Liposomal Irinotecan and 5-Fluorouracil/Leucovorin in Patients With Potentially Resectable Biliary Tract Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial is a prospective, single-arm, single-center Phase II study to evaluate the success, safety, and tolerability of surgical conversion of Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV in patients with potentially resectable biliary malignancies. The study included a screening period (no more than 28 days after subjects signed informed consent to the first treatment), a treatment period (including in-treatment visits and end-of-treatment visits), and a follow-up period (including safety visits, disease progression visits, and survival visits). After signing the informed consent, the subjects underwent a screening period within 28 days prior to the initial treatment to determine their eligibility for the study. After the subjects signed the informed consent, the subjects who met the screening criteria were selected to receive Ivonescimab combined with irinotican liposome injection and 5-FU/LV, administered once every 3 weeks, and then given radical surgical treatment at an elective time after 3 cycles. Successful conversion subjects resumed treatment within 8 weeks after surgery and received Ivonescimab combined with irinotecan liposome injection and 5-FU/LV every 3 weeks, and continued to receive Ivonescimab treatment for 1 year after 3 cycles. The safety of the medication is evaluated, and depending on the severity of adverse events (AE) that occur and are associated with the drug, the investigator will take measures to ensure the safety of the subject. After the final dosing, each subject will receive at least 30 days of follow-up AE monitoring and at least 90 days of follow-up SAE monitoring to evaluate subsequent safety. Biomarkers for predictive efficacy will also be explored, biomarker blood and tumor samples will be collected at baseline and during the trial for subjects who have signed up for biomarker sample collection/collection. Administration regimen: 1. Ivonescimab: 20mg/kg, d1, ivgtt, Q3W 2. Irinotecan liposomes: 70mg/m2, d1, ivgtt, Q3W 3. Calcium folinate 400mg/m2, d1, ivgtt, Q3W 4.5-FU 2400mg/m2, d1, ivgtt, Q3W

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab+chemotherapy	Dosing Schedule: 1. Ivonescimab: 20 mg/kg, Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 2. Irinotecan Liposome: 70 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 3. Calcium Folinate (LV): 400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 4. 5-FU: 2400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).

Timeline

• Start date: 2025-05-25
• Primary completion: 2026-04-25
• Completion: 2027-04-25
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

2 sites across 1 country: China