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

NCT07130240 | Recruiting Phase 2

• 1 other identifier: YIWX-CER-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancers

Outcome Measures

Primary Outcomes (2)

• 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.

  6-9 weeks

• 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.

  3 months

Secondary Outcomes (4)

• OS (Overall Survival)

  2 years

• DFS (Disease Free Survival)

  2 years

• Adverse Events

  2 years

• Changes in tumor-related biomarkers

  3 months

Study Arms (1)

neoadjuvant Ivonescimab combined with paclitaxel and cisplatin

EXPERIMENTAL

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

Drug: Neoadjuvant Chemotherapy Combined with Immunotherapy

Interventions

Neoadjuvant Chemotherapy Combined with Immunotherapy DRUG

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 3 cycles of neoadjuvant therapy, patients who achieved CR/PR will undergo Type A hysterectomy + sentinel lymph node dissection / pelvic lymphadenectomy

neoadjuvant Ivonescimab combined with paclitaxel and cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.
• Treatment with systemic immunostimulants, colony-stimulating factors, interferons, interleukins, or combination vaccines within 6 weeks or 5 half-lives (whichever is shorter) before the first dose.
• Diagnosis of immunodeficiency or chronic systemic steroid therapy (exceeding 10 mg prednisone equivalent per day) or any other form of immunosuppressive therapy within 7 days before the first dose.
• Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years.
• History of (non-infectious) pneumonitis requiring steroid treatment or current (non-infectious) pneumonitis.
• Active infection requiring systemic treatment.
• Known history of HIV infection.
• Known history of hepatitis B (defined as HBsAg reactivity) or active hepatitis C virus infection (defined as detectable HCV RNA \[qualitative\]).
• Known history of active tuberculosis (TB; Mycobacterium tuberculosis).
• Prior allogeneic tissue/solid organ transplantation.
• Central nervous system metastases, such as brain metastases.
• Uncontrolled pleural or peritoneal effusion.
• Impaired mobility due to pathological fractures caused by bone metastases.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

Study Sites (1)

The Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Junjun Qiu, PhD

CONTACT

+8618017738139; qiu_junjun@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of gynecological oncology

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2030
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)