ALA-PDT for cervical LSIL with HPV16/18 in multiple centers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, non-randomized controlled trial compares ALA-PDT treatment to observation for cervical LSIL associated with HPV16/18. The primary outcome is how often the cervical lesion regresses, with secondary outcomes including HPV clearance, time to clearance, improvements in cervical ectropion and vaginal microenvironment, lesion progression, recurrence, safety, tolerability, and quality of life. Participants are women aged 20–60 with HPV16/18-positive LSIL confirmed by colposcopy-guided biopsy, who consent to participate. Exclusion criteria include higher-grade cytology, invasive cancer suspicion, inflammatory conditions, certain medical comorbidities, pregnancy, or immunodeficiency. The study is led by Zhejiang University’s Second Affiliated Hospital with several collaborating centers in Hangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Women's Hospital School Of Medicine Zhejiang University
  Hangzhou, Zhejiang, China Recruiting
• First People's Hospital of Hangzhou
  Hangzhou, Zhejiang, China Not yet recruiting
• Hangzhou Linping District first People's Hospital
  Hangzhou, Zhejiang, China Not yet recruiting
• First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Not yet recruiting
• Shaoxing People's Hospital
  Shaoxing, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Xiaoyun Wang, Doctor
• Email: doctorwangxy@zju.edu.cn
• Phone: +86 0571-87783759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.