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Clinical Trials in China / NCT07669363
Starting soon Phase 2

Hexaminolevulinate Photodynamic Therapy (HAL-PDT) With Deferred Surgery Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)

NCT07669363 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2026-07-01
Last updated
2026-07-09

Condition(s) studied

Cervical Intraepithelial NeoplasiaPapillomavirus Infections

Investigational drug(s) / intervention(s)

Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC)HAL 5% with illumination

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).

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Days
Max age
Healthy volunteers
No
Inclusion Criteria: * Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form. * Able to complete the study in accordance with the study protocol. * Subject age ≥18 years. * Presence of High-Grade Squamous Intraepithelial Lesion (HSIL) (CIN2 P16 positive/CIN3), specifically: HSIL with histopathological diagnosis of grade II/III (CIN2 P16 positive/CIN3) within 3 months prior to the first treatment. * Adequate colposcopy, including: (a) Complete visibility of the cervical transformation zone, including the squamocolumnar junction; (b) Complete visibility of lesion margins. * The investigator determines that non-surgical treatment is acceptable for the participant. * The investigator determines that the cervical size is suitable for placement of the HAL-PDT device. * Meets the following conditions: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result prior to the start of treatment. No plan for pregnancy during the study period; no sexual activity or use of effective and reliable contraception from the end of the last menstrual period to the start of the study, and agreement to use condoms for barrier contraception during the study period. WOCBP is defined as a female who has experienced menarche, has not undergone hysterectomy or bilateral oophorectomy, and has not reached natural menopause (i.e., no menstruation at all for the past 24 consecutive months). Exclusion Criteria: * Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions. * CIN2 with P16 negative. * Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva. * Prior physical or surgical treatment to the cervix resulting in incomplete cervical structure (e.g., cold knife conization), or receipt of physical or surgical therapy for CIN2 or CIN3 after the current histopathological diagnosis. * The first study treatment day falls within 7 half-lives of the last antiviral medication. * Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination. * Investigator judges that vaginal bleeding during treatment may affect treatment outcomes. * Receipt of any inactivated vaccine within 2 weeks prior to the first treatment, or any live vaccine within 4 weeks prior to the first treatment. * Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years. * History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency. * Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment. * Presence of a cardiac pacemaker. * Suspected or known porphyria, or known allergy to the study drug, its chemically similar compounds, or photosensitizers. * Allergy to silicone. * Pregnant or breastfeeding women. * Delivery or miscarriage within 6 weeks prior to enrollment. * Participation in any other clinical trial within 30 days prior to study treatment. * Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
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

More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China

Other trials for the same condition

Official registry record

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