🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07306260
Starting soon Not applicable

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

NCT07306260 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2026-01
Last updated
2025-12-29

Condition(s) studied

HSIL, High Grade Squamous Intraepithelial LesionCIN 2HPV (Human Papillomavirus)-AssociatedPhotodynamic Therapy (PDT)

Investigational drug(s) / intervention(s)

ALA-PDTLEEP surgery

ALA-PDT: Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.

LEEP surgery: After anesthesia, cervical iodine staining was performed, followed by LEEP.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang
First People's Hospital of Hangzhou Hangzhou Zhejiang
Hangzhou Linping District first People's Hospital Hangzhou Zhejiang
First Affiliated Hospital of Ningbo University Ningbo Zhejiang
Shaoxing People's Hospital Shaoxing Zhejiang

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07306260 on ClinicalTrials.gov ↗ ← All trials in China