Cervical cancer ranks fourth globally in both incidence and mortality rates, making early diagnosis and treatment of great significance. For early-stage cervical cancer, surgery remains the primary treatment approach. According to the latest NCCN guidelines, patients with Stage IA2 or IB1 cervical cancer confirmed by cone biopsy who meet Concerv or SHAPE criteria no longer require type C/B hysterectomy. Instead, they may undergo type A hysterectomy with reduced surgical margins. However, patients with Stage IB2 or IIA1 tumors measuring 2-4 cm still require radical hysterectomy (type C). Radical hysterectomy carries high risks of postoperative complications and significantly impairs quality of life, including major vascular injury, urinary tract damage and dysfunction, lymphatic complications, and sexual dysfunction. Therefore, there is an imperative need to explore alternative or refined treatment approaches for Stage IB2/IIA1 cervical cancer that ensure survival outcomes while reducing surgical morbidity and improving quality of life.
Neoadjuvant therapy followed by scale-reduced surgery may represent a feasible strategy. Both immune escape and angiogenesis are core drivers of tumorigenesis and progression. Combined immunotherapy and anti-angiogenic therapy have demonstrated favorable antitumor efficacy and manageable safety profiles across multiple tumor types. Ivonescimab is a novel humanized tetrameric IgG-scFv bispecific antibody targeting PD-1 and VEGF. Mechanistically, PD-1 blockade reverses T-cell suppression while VEGF inhibition curbs neovascularization, yielding synergistic therapeutic enhancement. This agent has shown promising efficacy and safety in advanced non-small cell lung cancer, hepatocellular carcinoma, and recurrent glioblastoma, though clinical data in cervical cancer remain absent. Therefore, this prospective exploratory study aims to evaluate the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin followed by type A hysterectomy for stage IB2/IIA1 cervical cancer. The findings may provide novel insights for optimizing treatment paradigms-ensuring survival outcomes while preserving quality of life.
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Histological subtypes or disease stages other than those permitted in inclusion criteria (1) and (2).
Severe hypersensitivity (≥ Grade 3) to cisplatin, paclitaxel, Ivonescimab , and/or any of their excipients.
Participation in another clinical trial within 4 weeks prior to enrollment.
Administration of inactivated vaccines within 30 days before the first study treatment or planned vaccination during the study period.
Single group
Neoadjuvant Chemotherapy Combined with Immunotherapy
DrugDrug: Neoadjuvant Chemotherapy paclitaxel, 135-175mg/m2, q3w, 2-3 cycles Drug: Neoadjuvant Chemotherapy cisplatin, 75-80mg/m2, q3w, 2-3 cycles Drug: Immunotherapy Ivonescimab, 20mg/kg, q3w, 2-3cycles Procedure: Type A hysterectomy After 3 cycles of neoadjuvant therapy, patients who achieved CR/PR will undergo Type A hysterectomy + sentinel lymph node dissection / pelvic lymphadenectomy
Objective Response Rate (ORR)
ORR measures the proportion of patients whose cervical cancer shows a complete response (CR) or partial response (PR) to neoadjuvant therapy in this study. Complete Response (CR) means total disappearance of all detectable tumors and partial Response (PR) means significant reduction in tumor size larger than 30% according to RECIST guidelines.
Pathological Complete Response (pCR)
Pathological Complete Response (pCR) refers to the absence of detectable cancer cells in the tissue removed during surgery after neoadjuvant therapy which is examined under a microscope by a pathologist.
OS (Overall Survival)
DFS (Disease Free Survival)
Adverse Events
Changes in tumor-related biomarkers
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