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

NCT07306247 | Not Yet Recruiting

• 1 other identifier: 2025-1380
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

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

Keywords

cervical low-grade squamous intraepithelial lesions; aminolevulinic acid-mediated photodynamic therapy; efficacy; human papillomavirus

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• HPV clearance rate

  2 years

• Cervical lesion regression rate

  2 years

Other Outcomes (1)

• Adverse events

  2 years

Study Arms (2)

ALA-PDT Group

EXPERIMENTAL

ALA-PDT administered every 7-14 days for a total of 3-6 sessions.

Procedure: ALA-PDT

Observation Group

NO INTERVENTION

Observation and follow-up

Interventions

ALA-PDT PROCEDURE

Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.

ALA-PDT Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Use of interferon or antiviral therapy within 3 months;
• Any other condition deemed unsuitable for participation by the investigator.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• 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

Study Sites (5)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Location

Hangzhou Linping District first People's Hospital

Hangzhou, Zhejiang, China

Location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 310000, China

Location

Shaoxing People's Hospital

Shaoxing, Zhejiang, 310000, China

Location

Related Publications (7)

• Li D, Wang Z, Liu Y, Zhou M, Xia B, Zhang L, Chen K, Zeng Y. Assessing the risk of high-grade squamous intraepithelial lesions (HSIL+) in women with LSIL biopsies: a machine learning-based study. Infect Agent Cancer. 2024 Dec 5;19(1):61. doi: 10.1186/s13027-024-00625-z.

  PMID: 39639322 RESULT

• Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.1016/j.pdpdt.2022.102807. Epub 2022 Mar 11.

  PMID: 35288319 RESULT

• Qiu L, Li J, Chen F, Wang Y, Wang Y, Wang X, Lv Q, Li C, Li M, Yang Q, Wu D, Zhang Y, Zhang Y, Zhang M, Zhang Y, Qie M, Zhou H, Zhou J, Zhao W, Xia B, Liang X, Cai Y, Teng Y, Huang Z, Sui L, Wei L, Di W. Chinese expert consensus on the clinical applications of aminolevulinic acid-based photodynamic therapy in female lower genital tract diseases (2022). Photodiagnosis Photodyn Ther. 2022 Sep;39:102993. doi: 10.1016/j.pdpdt.2022.102993. Epub 2022 Jul 1.

  PMID: 35781093 RESULT

• Wang X, Xu X, Ma Y, Tang Y, Huang Z. Comparative Study of 5-Aminolevulinic Acid-Mediated Photodynamic Therapy and the Loop Electrosurgical Excision Procedure for the Treatment of Cervical High-Grade Squamous Intraepithelial Lesions. Pharmaceutics. 2024 May 20;16(5):686. doi: 10.3390/pharmaceutics16050686.

  PMID: 38794347 RESULT

• Persson M, Elfstrom KM, Olsson SE, Dillner J, Andersson S. Minor Cytological Abnormalities and up to 7-Year Risk for Subsequent High-Grade Lesions by HPV Type. PLoS One. 2015 Jun 17;10(6):e0127444. doi: 10.1371/journal.pone.0127444. eCollection 2015.

  PMID: 26083247 RESULT

• Kusakabe M, Taguchi A, Sone K, Mori M, Osuga Y. Carcinogenesis and management of human papillomavirus-associated cervical cancer. Int J Clin Oncol. 2023 Aug;28(8):965-974. doi: 10.1007/s10147-023-02337-7. Epub 2023 Jun 9.

  PMID: 37294390 RESULT

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 RESULT

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoyun Wang, Doctor

CONTACT

+86 0571-87783759; doctorwangxy@zju.edu.cn

Jianwei Zhou, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)