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.
Able to understand and voluntarily sign the written informed consent form before any study-specific procedures.
Female participants aged ≥18 years on the day of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Expected survival time ≥3 months.
Cervical cancer of non-eligible histology (e.g., neuroendocrine carcinoma, sarcoma).
Evidence of distant metastasis, including inguinal lymph node metastasis or lymph node involvement above L1 vertebral level.
History of total hysterectomy (removal of uterus and cervix). Subtotal hysterectomy or cornuostomy preserving the cervix is acceptable.
Anatomical or geometric contraindications to brachytherapy.