Cervical high-grade squamous intraepithelial lesion (HSIL/CIN2)
Conditions
Interventions
LEEP group:LEEP surgery
PDT group:Eila Photodynamic Therapy
Sponsors
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
Female
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Female, aged 25–60, able to provide informed consent for participation in the clinical trial; 2.Histologically confirmed HSIL/CIN2 via colposcopy-guided cervical biopsy within the past 3 months; 3.Willing to participate and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Cytological findings of ASC-H, HSIL, AGC, or AIS; or detection of malignant cells in cytology or histology; or suspicion of malignancy or invasive cancer; 2.Colposcopy cannot exclude invasive cancer or lesion extension to the vaginal wall; 3. Severe pelvic, cervical, or other significant gynecological inflammation identified on clinical examination; 4.Undiagnosed vaginal bleeding; 5.Active allergic disease; or suspected or confirmed porphyria; or history of hypersensitivity to the test drug or structurally similar compounds; 6.Severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, hepatic, or hematopoietic disorders; known severe immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or history of other malignancies; 7. Pregnancy or lactation; 8.History of hysterectomy, cervical cancer treatment, or cervical resection/ablation (e.g., conization, LEEP, laser) within 6 months; 9.Treatment with interferon or antiviral agents within the past 3 months; 10.Any other condition that, in the investigator’s judgment, makes the subject unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion reversal rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Lesion cure rate;Cervical anatomy and function;HPV clearance rate; | — |
Countries
China
Contacts
Public ContactWang Xiaoyun
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed