This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Female, 20-60 years, understands study procedures and consents to participate;
HPV 16 or 18 positive;
Colposcopy-guided cervical biopsy within 3 months showing LSIL;
Provides written informed consent.
Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
Undiagnosed vaginal bleeding;
Parallel
ALA-PDT
Procedure/SurgeryPhotosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
Cervical lesion regression rate
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
HPV clearance rate
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
Cervical lesion regression rate
Proportion of patients with normal colposcopy-guided cervical biopsy histopathology, or NILM cytology plus negative HPV test, at 12 and 24 months.
Adverse events
Record post-treatment bleeding, pain, and photosensitivity.
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborator
First People's Hospital of Hangzhou
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Shaoxing People's Hospital
Collaborator
Linping First People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
