Clinical Trial

Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer

Not Yet Recruiting Phase 2
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Summary
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Eligible participants will receive two cycles of neoadjuvant Ivonescimab plus TP chemotherapy, followed by standard concurrent chemoradiotherapy. The primary endpoints include progression-free survival (PFS) and objective response rate (ORR) following neoadjuvant treatment. Secondary endpoints include overall survival (OS), disease control rate (DCR), safety, and quality of life (EORTC QLQ-C30). Exploratory analysis will focus on identifying predictive biomarkers for Ivonescimab efficacy.
Trial Details
NCT Number NCT07244965
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Conditions LOCALLY ADVANCED CERVICAL CANCERS
Enrollment 42 participants
Start Date 2025-12-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2029-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-24