NCT07130240

Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 and IIA1 Cervical Cancer

Recruiting now Phase 2 Last updated 19 August 2025

What this trial tests

Phase 2 trial testing Neoadjuvant Chemotherapy Combined with Immunotherapy in Cervical Cancers in 20 participants. Currently enrolling.

Timeline

15 August 2025

Primary endpoint
31 August 2028

31 August 2030

Quick facts

Lead sponsor	Obstetrics & Gynecology Hospital of Fudan University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 August 2025
Primary completion	31 August 2028
Estimated completion	31 August 2030
Sites	1 location across China

Drugs / interventions tested

• Neoadjuvant Chemotherapy Combined with Immunotherapy — full drug profile →

Conditions studied

• Cervical Cancers — all drugs for Cervical Cancers →

Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Who can join

Adults 18 to 75, female only, with Cervical Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.