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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура ALA-PDT
  Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
• Процедура LEEP surgery
  After anesthesia, cervical iodine staining was performed, followed by LEEP.

Первичные конечные точки

• Lesion effective rate [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Lesion effective rate [Срок оценки: 2 years]
• HPV clearance rate [Срок оценки: 2 years]
• Lesion cure rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Women's Hospital School Of Medicine Zhejiang University — Ханчжоу
• First People's Hospital of Hangzhou — Ханчжоу
• Hangzhou Linping District first People's Hospital — Ханчжоу
• First Affiliated Hospital of Ningbo University — Ningbo
• Shaoxing People's Hospital — Shaoxing

Идентификаторы

NCT: NCT07306260 · 2025-1382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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