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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• (1)Patients with FIGO 2018 stages IB2, IIA1 (2\< lesion ≤4 cm, confirmed by MRI); (2) Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma; (3)18-75 years old. (4) ECOG performance status score: 0-1. (5) No prior therapy received by the participant. (6)Expected survival period ≥6 months. (7) Women of childbearing potential must agree to use contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after the study ends. A negative serum or urine pregnancy test within 7 days before study enrollment is required, and the patient must not be breastfeeding.

• (8) Adequate organ function as defined by the protocol, with test samples collected within 7 days before the start of study treatment.

• (9) Participants voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.

Locations
Other Locations
China
The Obstetrics & Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Junjun Qiu, PhD
qiu_junjun@fudan.edu.cn
+8618017738139
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2030-08-31
Participants
Target number of participants: 20
Treatments
Experimental: neoadjuvant Ivonescimab combined with paclitaxel and cisplatin
Drug: 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 2-3 cycles of neoadjuvant therapy, patients who achieve CR/PR (evaluated by MRI) and meet SHAPE criteria will receive Type A hysterectomy plus sentinel lymph node dissection / pelvic lymphadenectomy
Sponsors
Leads: Obstetrics & Gynecology Hospital of Fudan University

This content was sourced from clinicaltrials.gov