Exploratory Study of the Efficacy of HAL-PDT in CIN 3

This is a prospective, multicenter, biomarker-guided Phase II study evaluating the efficacy and safety of hexaminolevulinate-mediated cervical photodynamic therapy (HAL-PDT) in women with cervical intraepithelial neoplasia grade 3 (CIN3). Approximately 260 women aged 18 to 50 years with histologically confirmed CIN3 and a positive baseline human papillomavirus (HPV) test will be enrolled. Participants will receive HAL-PDT using a 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Treatment will be administered once every 2 weeks for a total of 6 treatments. The primary objective is to evaluate the overall efficacy of HAL-PDT, measured by the pathological regression rate at 6 months after the first treatment. Pathological regression is defined as biopsy findings showing normal cervical tissue or low-grade squamous intraepithelial lesion (LSIL/CIN1). The study will also evaluate pathological regression at 12 months, HPV clearance at 3, 6, and 12 months, treatment-related adverse events, changes in cervical lesion characteristics, and the associations between HPV integration status and treatment response. Cervical exfoliated-cell methylation status and p16/Ki-67 dual-stain status will also be assessed during follow-up.