Neoadjuvant chemotherapy plus cadonilimab followed by extra-fascial hysterectomy for International Federation of Gynecology and Obstetrics stage IB2 cervical cancer: a prospective, multi-center, single-arm, phase 2 trial.
Yingjie Hu, Hanxu Cheng, Jing Chen et al.
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In 30 seconds
This prospective, multicentre, single-arm phase II trial is evaluating whether neoadjuvant chemoimmunotherapy can enable less extensive surgery for treatment-naïve patients with FIGO 2018 stage IB2 cervical cancer. Participants receive three cycles of nab-paclitaxel, cisplatin, and cadonilimab; those with post-treatment tumours ≤2 cm who meet ConCerV-based cone-biopsy criteria undergo extra-fascial hysterectomy, while others proceed to radical hysterectomy. The primary endpoint is the proportion meeting those criteria after treatment. The planned sample is 50, and recruitment and outcome analysis are not yet complete; the abstract reports no efficacy results.
Key findings
- The trial plans to enrol 50 patients with treatment-naïve FIGO 2018 stage IB2 cervical cancer.
- After three cycles of chemoimmunotherapy, extra-fascial hysterectomy is planned for patients with tumours ≤2 cm who meet ConCerV-based criteria.
- The primary endpoint is the proportion meeting the pre-defined criteria; no trial outcomes are reported in the abstract.
Why it matters
Radical hysterectomy can be associated with peri-operative and long-term complications that affect quality of life. This study tests whether tumour response and risk assessment after neoadjuvant chemoimmunotherapy can identify patients suitable for a less extensive operation. Its results may clarify feasibility, but the abstract provides a trial protocol rather than evidence of safety or effectiveness.
What to keep in mind
This is a single-arm phase II trial, so it has no concurrent comparison group. Recruitment and analysis are pending, and the abstract reports no clinical outcomes.