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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06993025
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab+chemotherapy — DRUG
    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).

Study Details

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.

Key Dates

Start date
May 25, 2025
Status verified
Apr 2025
Primary completion
Apr 25, 2026
Completion
Apr 25, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab+chemotherpy
    After signing informed consent, subjects who meet the inclusion criteria following screening will receive Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles, followed by scheduled radical surgery. Subjects who achieve successful conversion will resume treatment within 8 weeks after surgery and continue with Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles. Subsequently, they will receive Ivonescimab monotherapy until 1 year of treatment is completed. 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).

Primary Outcome Measure

surgical conversion success rate [ Time Frame: From the start of conversion therapy until surgical evaluation or resection, or until it is determined that surgical resection is not feasible. ]

Central Contacts

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