HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2

This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.

NCT Number	NCT07634497
Lead Sponsor	Peking Union Medical College Hospital
Conditions	Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
Enrollment	500 participants
Start Date	2026-06-15
Primary Completion	2028-06-15 (estimated)
Study Completion	2029-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-16