Study of Ivonescimab with Paclitaxel and Cisplatin Before Less Extensive Surgery in Women with Stage IB2 and IIA1 Cervical Cancer

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 IB2IIA1 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.

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