Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2 (PDT for CIN2)

Zhejiang University

Status: Not yet enrolling

Conditions: CIN 2; HSIL, High Grade Squamous Intraepithelial Lesion; Photodynamic Therapy (PDT); HPV (Human Papillomavirus)-Associated

Treatments: Procedure: ALA-PDT; Procedure: LEEP surgery

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07306260

2025-1382

Details and patient eligibility

About

This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Full description

This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.

Enrollment: 560 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female, 25-60 years, understands study procedures and consents to participate;
2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
3. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

ALA-PDT Group

Experimental group

Description:

ALA-PDT treatment for cervical lesions 6 to 9 times

Treatment:

Procedure: ALA-PDT

LEEP Group

Active Comparator group

Description:

LEEP surgery for cervical lesions

Treatment:

Procedure: LEEP surgery