Actively Recruiting
Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 and IIA1 Cervical Cancer
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-08-19
20
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 and IIA1 Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with FIGO 2018 stages IB2 or IIA1 cervical cancer with tumor size between 2 and 4 cm confirmed by MRI
- Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Age between 18 and 75 years
- ECOG performance status score of 0 or 1
- No prior therapy for cervical cancer
- Expected survival of at least 6 months
- Women of childbearing potential must agree to use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
- Adequate organ function confirmed by tests within 7 days before treatment start
- Voluntary participation with signed informed consent and willingness to comply with study procedures and follow-up
You will not qualify if you...
- Histological subtypes or disease stages other than those included
- Severe allergic reactions (grade 3 or higher) to cisplatin, paclitaxel, Ivonescimab, or their components
- Participation in another clinical trial within 4 weeks before enrollment
- Receiving inactivated vaccines within 30 days before first treatment or planned vaccination during study
- Treatment with systemic immunostimulants, colony-stimulating factors, interferons, interleukins, or combination vaccines within 6 weeks or 5 half-lives before first dose
- Immunodeficiency or chronic systemic steroid therapy exceeding 10 mg prednisone equivalent per day within 7 days before first dose
- Active autoimmune disease requiring systemic treatment within the past 2 years
- History or current non-infectious pneumonitis requiring steroid treatment
- Active infection requiring systemic treatment
- Known history of HIV, hepatitis B or C infection, or active tuberculosis
- Prior allogeneic tissue or organ transplantation
- Central nervous system metastases
- Uncontrolled pleural or peritoneal effusion
- Impaired mobility due to pathological fractures from bone metastases
- Insufficient bone marrow function without recent transfusion
- Liver abnormalities beyond specified limits
- Kidney abnormalities beyond specified limits
- Bleeding risk factors including coagulation abnormalities, history of bleeding, or recent severe bleeding events
- Cardiovascular or cerebrovascular conditions within 12 months before first dose
- Other conditions judged by investigators to affect study results or patient safety, such as alcoholism, drug abuse, severe diseases including mental illness, significant lab abnormalities, or social factors
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Junjun Qiu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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