Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2

This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Inclusion Criteria: 1. Female, 25-60 years, understands study procedures and consents to participate; 2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2; 3. Provides written informed consent. Exclusion Criteria: 1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer; 2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall; 3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically; 4. Undiagnosed vaginal bleeding; 5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents; 6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies; 7. Pregnant or breastfeeding women; 8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser); 9. Use of interferon or antiviral therapy within 3 months; 10. Any other condition deemed unsuitable for participation by the investigator.