drugset / Trial / NCT07854600

A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer

NCT07854600 ↗

Phase 2 Recruiting 87 enrolled Haitao Zhao, MD
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to explore the efficacy and safety of Ivonescimab in combination with GEMOX chemotherapy as neoadjuvant and conversion therapy for patients with biliary tract cancer. It aims to evaluate the impact of this combination regimen on postoperative recurrence, patient survival, and medication safety. This is a single-center, phase II, interventional, single-arm, multi-cohort clinical study. A total of 87 eligible participants will be enrolled and assigned to either the neoadjuvant therapy cohort (45 participants) or the conversion therapy cohort (42 participants).

Timeline

Start
2026-10
Primary completion
2028-10
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Ivonescimab Monoclonal antibody 20 mg/kg Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous

Indications