EICHORCondition: Cervical Intraepithelial Neoplasia · Papillomavirus Infections · Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
Always discuss trial participation with your own doctor first.
| Fujian Medical University Union Hospital | Fuzhou, Fujian, China | — |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou, Fujian, China | — |
| Xiamen Maternity and Child Healthcare Hospital | Xiamen, Fujian, China | — |
| he First Affiliated Hospital of Xiamen University | Xiamen, Fujian, China | — |
| The First People's Hospital of Foshan | Foshan, Guangdong, China | — |
| Foshan Shunde Maternal and Child Health Hospital | Foshan, Guangdong, China | — |
| Guangdong Women and Children Hospital | Guangzhou, Guangdong, China | — |
| The Affiliated Cancer Hospital of Guangzhou Medical University | Guangzhou, Guangdong, China | — |
| Guangdong ProvincialHospital of Chinese Medicine | Guangzhou, Guangdong, China | — |
| Guangzhou First People's Hospital (The Second Affiliated Hospital of South China University of Technology) | Guangzhou, Guangdong, China | — |
| Zhujiang Hospital, Southern Medical University | Guangzhou, Guangdong, China | — |
| Guangdong Second Provincial GeneralHospital (Guangdong Provincial Emergency Hospital) | Guangzhou, Guangdong, China | — |
+ 16 more locations — full list on the registry record.
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07669363