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

NCT06993025 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-28

No results posted yet for this study

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.

Conditions

  • Biliary Tract Cancer

Interventions

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).

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2026-04-25
Completion
2027-04-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06993025 on ClinicalTrials.gov