Phase 2 Study of Neoadjuvant Chemotherapy Plus Camrelizumab for PD-L1-negative Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating the combination of neoadjuvant chemotherapy and the PD-1 inhibitor camrelizumab NACI for women with PD-L1-negative locally advanced cervical cancer. This phase 2, multicenter, single-arm trial aims to assess the treatments impact on tumor remission, surgical complications, positive margin rates, and survival. The study also explores changes in immune factors and tumor cells during treatment and seeks biomarkers that may affect therapy effectiveness. Participants first receive one cycle of platinum-based doublet priming chemotherapy. After three weeks, they receive two cycles of camrelizumab combined with chemotherapy every 21 days. Those with stable or progressive disease proceed to concurrent chemoradiotherapy, while patients showing complete or partial response undergo radical surgery including hysterectomy and lymphadenectomy. Throughout the study, participants undergo evaluations of tumor response, surgery outcomes, and survival for up to seven years. Researchers monitor pathologic complete response after surgery and track surgical complications, objective response rates, positive margin rates, and patient-reported outcomes. Safety and adverse events are assessed over long-term follow-up, with adherence and willingness to comply being key participation factors.

Neoadjuvant Immunochemotherapy in PD-L1-negative LACC