ALA-PDT: Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
Study summary
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Eligibility
Sex
FEMALE
Min age
20 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Female, 20-60 years, understands study procedures and consents to participate;
2. HPV 16 or 18 positive;
3. Colposcopy-guided cervical biopsy within 3 months showing LSIL;
4. 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)
Cervical lesion regression rate — 6 months Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
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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