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ClinicalTrials.gov ID

NCT07306247

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

225Estimated

Last Update Posted

Dec 29, 2025Actual

Start Date

Jan 2026Estimated

Primary Completion Date

Jan 2027Estimated

Completion Date

Dec 2027Estimated

Official Title

Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical Low-grade Squamous Intraepithelial Lesions With HPV16/18 Infection

Brief Summary

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

Detailed Description

This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.

• HPV-16/18
• Photodynamic Therapy (PDT)
• LSIL, Low Grade Squamous Intraepithelial Lesion

• ALA-PDT

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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 Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Collaborators

Women's Hospital School Of Medicine Zhejiang UniversityOTHER

First People's Hospital of HangzhouOTHER

First Affiliated Hospital of Ningbo UniversityNETWORK

Shaoxing People's HospitalOTHER

Linping First People's HospitalUNKNOWN

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