OncoMatch/Clinical Trials/NCT07130240
Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 and IIA1 Cervical Cancer
Is NCT07130240 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant Chemotherapy Combined with Immunotherapy for cervical cancers.
Treatment: Neoadjuvant Chemotherapy Combined with Immunotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) <1.5×10⁹/L; Platelets <100×10⁹/L; Hemoglobin <9 g/dL (without transfusion within 14 days).
Kidney function
Serum creatinine >1.5×ULN or estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula; Urinalysis showing protein ≥++ and confirmed 24-hour urine protein >1.0 g; Renal failure requiring hemodialysis or peritoneal dialysis; History of nephrotic syndrome.
Liver function
ALT, AST, or ALP >2.5× ULN without liver metastasis or >5×ULN with liver metastasis; Total bilirubin >1.5×ULN (>3×ULN in patients with Gilbert's syndrome); Decompensated cirrhosis (Child-Pugh class B or C); HBsAg-positive with HBV DNA ≥2000 IU/mL (patients with HBsAg-positive and HBV DNA <2000 IU/mL must receive at least 2 weeks of anti-HBV therapy before the first dose); HCV antibody-positive with detectable HCV RNA.
Cardiac function
Any of the following within 12 months before the first dose: ≥ Grade 2 myocardial ischemia, myocardial infarction, arrhythmias, ≥ Grade 3 cardiac insufficiency, uncontrolled angina, coronary/peripheral artery bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack; Deep vein thrombosis or pulmonary embolism within 6 months before the first dose; Left ventricular ejection fraction (LVEF) <50% assessed by Doppler ultrasound; Average QTc interval corrected by Fridericia's formula (QTcF) (based on at least 3 consecutive ECG readings): ≥470 ms for females; Uncontrolled hypertension (at least 2 measurements showing systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
Adequate organ function as defined by the protocol... Insufficient bone marrow function... Liver abnormalities... Kidney abnormalities... Cardiovascular and cerebrovascular abnormalities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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