Overview
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.
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.
Eligibility
Inclusion Criteria:
- Female, 25-60 years, understands study procedures and consents to participate;
- Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
- Provides written informed consent.
Exclusion Criteria:
- 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.
