Neoadjuvant Ivonescimab Plus Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Locally Advanced Cervical Cancer
Neoadjuvant Ivonescimab Combined With Paclitaxel and Cisplatin, Followed by Concurrent Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer：A Phase II, Single-Arm Study
Sponsor: Women's Hospital School Of Medicine Zhejiang University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) Assessed by RECIST v1.1
Time frame: Up to 36 months
Secondary Endpoints
1-Year and 3-Year Progression-Free Survival (PFS) Rate
Objective Response Rate (ORR) After Concurrent Chemoradiotherapy
Disease Control Rate (DCR)
Eligibility Criteria
Inclusion Criteria: * Able to understand and voluntarily sign the written informed consent form before any study-specific procedures. * Female participants aged ≥18 years on the day of signing informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected survival time ≥3 months. * Histologically confirmed diagnosis of cervical cancer. * Histological types limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * No prior anti-tumor treatments (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy). Note: Lymph node dissection or biopsy for clinical staging is allowed. * FIGO 2018 stage III-IVA cervical cancer unsuitable for curative surgery. Lymph node metastasis may be confirmed by biopsy or imaging. Imaging-based lymph node metastasis must meet: MRI/CT showing positive lymph node with short-axis diameter ≥10 mm, and ≥15 mm to be used as target lesion. * At least one measu…
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