Not Yet RecruitingNot Applicable

Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection

China225 participantsStarted 2026-01

Plain-language summary

This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.

Age range20 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✕. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
✕. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
✕. Pregnant or breastfeeding women;
✕. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);

Cervical lesion regression rate

Timeframe: 6 months

NCT IDNCT07306247

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Xiaoyun Wang, Doctor

Who can participate

Age range20 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✕. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
✕. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
✕. Pregnant or breastfeeding women;
✕. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);