Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC): Subjects undergo immediate surgical excision of the cervical lesion via either Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC), as determined by the investigator based on the subject's individual lesion characteristics, size, and clinical presentation, following standard institutional surgical protocols.
HAL 5% with illumination: HAL-PDT is a drug-device combination product. The drug is hexaminolevulinate hydrochloride (HAL) 5% ointment. The device is a single-use cervical light delivery device (CL7) with integrated red LEDs. The ointment is applied into the device cup, placed against the cervix for 5 hours of drug absorption, then automatically delivers 125 J/cm² photodynamic therapy for 4 hours and 36 minutes. Total in-situ time is 11-24 hours. Patients remove the device themselves. Treatment regimen: one session every 2 weeks for a total of 6 sessions (Q2W × 6).
High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are precancerous conditions that require effective intervention. This Phase II study aims to comprehensively evaluate the efficacy, safety, and impact on quality of life of hexaminolevulinate photodynamic therapy (HAL-PDT) with deferred surgery compared to immediate surgical treatment in subjects with HSIL.
This is a prospective, open-label, randomized, controlled, non-inferiority trial. A total of 230 subjects are planned to be enrolled, with 115 subjects allocated to each treatment group (HAL-PDT with Deferred Surgery or Immediate Surgery ).
The primary endpoint is the pathological regression rate at 12 months, defined as histological findings of normal tissue or low-grade squamous intraepithelial lesions (LSIL) via colposcopy-directed biopsy. Key secondary endpoints include Human Papillomavirus (HPV) clearance rates at 6 and 12 months, pathological regression rate at 6 months, quality of life assessed by the EORTC QLQ-CX24 questionnaire, safety profiles (incidence, severity, and duration of AEs and SAEs, as well as their relationship to the study treatments), and the proportion of subjects developing cervical cancer within 12 months.
| Facility | City | Region | Status |
|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | |
| Xiamen Maternity and Child Healthcare Hospital | Xiamen | Fujian | |
| he First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| The First People's Hospital of Foshan | Foshan | Guangdong | |
| Foshan Shunde Maternal and Child Health Hospital | Foshan | Guangdong | |
| Guangdong Women and Children Hospital | Guangzhou | Guangdong | |
| The Affiliated Cancer Hospital of Guangzhou Medical University | Guangzhou | Guangdong | |
| Guangdong ProvincialHospital of Chinese Medicine | Guangzhou | Guangdong | |
| Guangzhou First People's Hospital (The Second Affiliated Hospital of South China University of Technology) | Guangzhou | Guangdong | |
| Zhujiang Hospital, Southern Medical University | Guangzhou | Guangdong | |
| Guangdong Second Provincial GeneralHospital (Guangdong Provincial Emergency Hospital) | Guangzhou | Guangdong | |
| The First AffiliatedHospital, Guangzhou University ofTraditional Chinese Medicine | Guangzhou | Guangdong | |
| Guangzhou Women and Children's Medical Center (The Affiliated Women and Children's Medical Center of Guangzhou Medical University) | Guangzhou | Guangdong | |
| Panyu Central Hospital Affiliated to Guangzhou Medical University | Guangzhou | Guangdong | |
| Shenzhen Maternity and Child Health Hospital | Shenzhen | Guangdong | |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University | Zhongshan | Guangdong | |
| Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital | Nanning | Guangxi | |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | |
| Dongguan Maternal and Child Health Care Hosptial | Dongguan | Guangzhou | |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | |
| The First Affiliated Hospital with Nanjing Medical University (Jiangsu Provincial People's Hospital) | Nanjing | Jiangsu | |
| The First Hospital of Jilin University | Changchun | Jinlin | |
| The General Hospital of Northern Theater Command of the Chinese People's Liberation Army | Shenyang | Liaoning | |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | |
| The West China Second University Hospital of Sichuan University | Chengdu | Sichuan | |
| Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) | Hangzhou | Zhejiang |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07669363 on ClinicalTrials.gov ↗ ← All trials in China