Neoadjuvant Chemotherapy and Cadonilimab Followed by Extrafascial Hysterectomy for Stage IB2 Cervical Cancer in a Phase 2 Multicenter Trial

What this Trial Is About

Researchers are investigating a new treatment approach for women with stage IB2 cervical cancer. This study explores the use of neoadjuvant chemoimmunotherapy combined with extrafascial hysterectomy and pelvic lymph node dissection. The goal is to assess treatment response, side effects, complications, and patient survival, focusing on a less invasive surgical option that may reduce complications compared to traditional radical hysterectomy. The treatment involves giving patients Cadonilimab, a bispecific immunotherapy drug, with chemotherapy drugs paclitaxel-albumin and cisplatin. These drugs are administered intravenously every three weeks for three cycles. After neoadjuvant treatment, patients undergo either extrafascial hysterectomy with pelvic lymphadenectomy or radical hysterectomy, depending on their response and eligibility according to specific criteria. Some participants may also have a cone biopsy if their tumor size reduces sufficiently. Participants will be closely monitored from before treatment through surgery and for several years afterward. Researchers will evaluate tumor response, survival rates, side effects, surgical complications, urinary function, and patient-reported outcomes. Follow-up assessments will occur regularly for up to seven years to observe long-term effects and safety. The primary measure is the percentage of patients meeting criteria for conservative surgery about two years after treatment.

Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer