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)
Lesion effective rate — 6 months Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
Trial sites (5)
Facility
City
Region
Status
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
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.
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