Actively Recruiting
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
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2025-08-19
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cervical cancer is a major health concern worldwide, ranking fourth in incidence and mortality among women. Early-stage cervical cancer typically involves surgery as the main treatment. Current guidelines suggest that patients with Stage IA2 or IB1 cervical cancer meeting certain criteria can have less extensive surgery (type A hysterectomy), but those with Stage IB2 or IIA1 tumors measuring 2-4 cm usually require a more radical surgery (type C hysterectomy), which carries significant risks and reduces quality of life. This study explores a new treatment approach for Stage IB2/IIA1 cervical cancer to maintain survival while reducing surgery-related complications. The study evaluates neoadjuvant therapy using Ivonescimab, a novel bispecific antibody targeting PD-1 and VEGF, combined with chemotherapy drugs paclitaxel and cisplatin. After 2 to 3 cycles of this combined treatment, patients who respond well will undergo a less extensive type A hysterectomy along with lymph node assessment. This approach aims to reduce the surgical impact compared to the traditional radical hysterectomy. Ivonescimab has shown promising results in other cancers, and this trial investigates its safety and effectiveness in early-stage cervical cancer. Participants will be monitored through MRI scans to assess tumor response before surgery and followed for up to two years to evaluate survival, disease-free status, adverse events, and tumor-related biomarkers. The main outcomes measured include tumor response rates within 6-9 weeks and complete pathological response at 3 months. Safety and long-term effects will also be tracked. The total study duration includes neoadjuvant therapy, surgery, and extended follow-up to understand the overall benefits and risks of this treatment strategy.
CONDITIONS
Brief 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...
- Women aged 18 to 75 years
- Diagnosed 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
- ECOG performance status score of 0-1
- No prior therapy for cervical cancer
- Expected survival of at least 6 months
- Women of childbearing potential agree to use contraception during the study and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
- Adequate organ function based on recent laboratory tests
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Histological subtypes or disease stages other than those specified in inclusion criteria
- Severe hypersensitivity (Grade 3 or higher) to cisplatin, paclitaxel, Ivonescimab, or their components
- Participation in another clinical trial within 4 weeks prior to enrollment
- Recent or planned vaccination with inactivated vaccines during the study
- Use of systemic immunostimulants or related therapies within 6 weeks before treatment
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 7 days before treatment
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current non-infectious pneumonitis requiring steroids
- Active infection requiring systemic treatment
- Known HIV, hepatitis B or C infection, active tuberculosis
- Prior allogeneic tissue or organ transplantation
- Central nervous system metastases
- Uncontrolled pleural or peritoneal effusion
- Mobility impairment due to bone metastases
- Insufficient bone marrow function without recent transfusion
- Significant liver or kidney abnormalities as defined by protocol
- Bleeding risks including coagulation abnormalities or recent bleeding events
- Cardiovascular or cerebrovascular conditions within specified recent timeframes
- Other conditions judged by investigator to affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 cycles of 3 weeks each
Participants receive neoadjuvant therapy consisting of chemotherapy drugs paclitaxel and cisplatin combined with the immunotherapy drug ivonescimab.
Up to 3 visits every 3 weeks for treatment administration
Duration - Single surgical procedure following neoadjuvant therapy
Participants who respond to neoadjuvant therapy undergo Type A hysterectomy plus sentinel lymph node dissection or pelvic lymphadenectomy.
1 visit (in-person) for surgery
Duration - Up to 2 years
Participants are monitored for recovery and safety after surgery and neoadjuvant treatment.
Regular follow-up visits over 2 years for monitoring survival, disease status, and adverse events
Trial Site Locations
Total: 1 location
1
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
J
Junjun Qiu, PhD
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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