Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical Low-grade Squamous Intraepithelial Lesions With HPV16/18 Infection
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 入组人数
- 225
- 试验地点
- 5
- 主要终点
- Cervical lesion regression rate
概览
简要总结
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
详细描述
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.
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
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
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
Cervical lesion regression rate
时间窗: 6 months
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
次要结局
- HPV clearance rate(2 years)
- Cervical lesion regression rate(2 years)