Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 560
- 试验地点
- 5
- 主要终点
- Lesion effective rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Lesion effective rate
时间窗: 6 months
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
次要结局
- Lesion effective rate(2 years)
- HPV clearance rate(2 years)
- Lesion cure rate(2 years)