[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643918":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":32,"responsibleParty":446,"collaborators":26,"id":449,"slug":450,"hasResults":451,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":451,"sex":457,"minAge":458,"maxAge":26,"enrollmentInfo":459,"targetDuration":26,"studyType":462,"phases":463,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":482,"whyStopped":26,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":492},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hexaminolevulinate Photodynamic Therapy (HAL-PDT) with Deferred Surgery","EXPERIMENTAL","Subjects receive Hexaminolevulinate Photodynamic Therapy (HAL-PDT) once every 2 weeks (Q2W) for a total of 6 treatment sessions. At 6 months after the first treatment, participants undergo colposcopy-directed cervical biopsy and HPV testing to assess treatment response. Those who achieve pathological remission (normal or LSIL) enter follow-up without surgery. Those who do not achieve remission (persistent HSIL or disease progression) receive standard surgical treatment (LEEP or CKC) within 4 weeks of the 6-month assessment.",[13],"Combination Product: HAL 5% with illumination",{"label":15,"type":16,"description":17,"interventionNames":18},"Immediate Surgery","ACTIVE_COMPARATOR","Participants with histologically confirmed HSIL (CIN2 P16 positive\u002FCIN3) receive standard surgical treatment (LEEP or CKC) per routine clinical practice. Follow-up assessments include HPV testing and colposcopy-directed cervical biopsy at 6 months and 12 months post-surgery to evaluate pathological remission and HPV clearance rates. Safety monitoring is conducted from signing of informed consent through the end of study.",[19],"Procedure: Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"COMBINATION_PRODUCT","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\u002Fcm² 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).",[9],[33,55,67,82,95,112,125,141,153,166,178,191,204,216,228,240,256,268,286,303,316,332,348,364,380,396,413,430],{"facility":34,"status":26,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001","China","CN",{"type":41,"coordinates":42},"Point",[43,44],119.30611,26.06139,{"lat":44,"lon":43},[47,52],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"Ethics Committee Administrator","CONTACT","0591-83357896","fjxhe_irb@163.com",{"name":53,"role":54,"phone":26,"phoneExt":26,"email":26},"Dezhao Chen, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":56,"status":26,"city":35,"state":36,"zip":57,"country":38,"countryCode":39,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"The First Affiliated Hospital of Fujian Medical 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Hospital)","510317",{"type":41,"coordinates":195},[131,132],{"lat":132,"lon":131},[198,202],{"name":199,"role":49,"phone":200,"phoneExt":26,"email":201},"Administrator Clinical Research Office","+86-20-89168338","gdech_irb@163.com",{"name":203,"role":54,"phone":26,"phoneExt":26,"email":26},"Xiafei Fu, MD, PhD",{"facility":205,"status":26,"city":127,"state":98,"zip":206,"country":38,"countryCode":39,"cosmosGeoPoint":207,"geoPoint":209,"contacts":210},"The First AffiliatedHospital, Guangzhou University ofTraditional Chinese Medicine","510405",{"type":41,"coordinates":208},[131,132],{"lat":132,"lon":131},[211,214],{"name":48,"role":49,"phone":212,"phoneExt":26,"email":213},"+86-20-36588667","gztcmlunli@163.com",{"name":215,"role":54,"phone":26,"phoneExt":26,"email":26},"Sijin Li, MD, PhD",{"facility":217,"status":26,"city":127,"state":98,"zip":218,"country":38,"countryCode":39,"cosmosGeoPoint":219,"geoPoint":221,"contacts":222},"Guangzhou Women and Children's Medical Center (The Affiliated Women and Children's Medical Center of Guangzhou Medical University)","510623",{"type":41,"coordinates":220},[131,132],{"lat":132,"lon":131},[223,226],{"name":48,"role":49,"phone":224,"phoneExt":26,"email":225},"020-81886332","gzwc_irb@163.com",{"name":227,"role":54,"phone":26,"phoneExt":26,"email":26},"Kun Shi, MD, PhD",{"facility":229,"status":26,"city":127,"state":98,"zip":230,"country":38,"countryCode":39,"cosmosGeoPoint":231,"geoPoint":233,"contacts":234},"Panyu Central Hospital Affiliated to Guangzhou Medical University","511400",{"type":41,"coordinates":232},[131,132],{"lat":132,"lon":131},[235,238],{"name":48,"role":49,"phone":236,"phoneExt":26,"email":237},"020-34858888","pyzxylunli@163.com",{"name":239,"role":54,"phone":26,"phoneExt":26,"email":26},"Xiang Yang, MD, PhD",{"facility":241,"status":26,"city":242,"state":98,"zip":243,"country":38,"countryCode":39,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Shenzhen Maternity and Child Health Hospital","Shenzhen","518031",{"type":41,"coordinates":245},[246,247],114.0683,22.54554,{"lat":247,"lon":246},[250,254],{"name":251,"role":49,"phone":252,"phoneExt":26,"email":253},"Liu","+86-0755-83579801","szfygcpll@163.com",{"name":255,"role":54,"phone":26,"phoneExt":26,"email":26},"Ping Jin, MD, PHD",{"facility":257,"status":26,"city":242,"state":98,"zip":258,"country":38,"countryCode":39,"cosmosGeoPoint":259,"geoPoint":261,"contacts":262},"Peking University Shenzhen Hospital","518036",{"type":41,"coordinates":260},[246,247],{"lat":247,"lon":246},[263,266],{"name":48,"role":49,"phone":264,"phoneExt":26,"email":265},"0755-83923333","pkuszh_irb@163.com",{"name":267,"role":54,"phone":26,"phoneExt":26,"email":26},"Zhihong Liu, MD, PhD",{"facility":269,"status":26,"city":270,"state":98,"zip":271,"country":38,"countryCode":39,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"The First Affiliated Hospital, Sun Yat-sen University","Zhongshan","510080",{"type":41,"coordinates":273},[274,275],113.37912,22.52306,{"lat":275,"lon":274},[278,282,284],{"name":279,"role":49,"phone":280,"phoneExt":26,"email":281},"Ying Lin","+86-020-87330631（FAX）","zsyyiec2020@mail.sysu.edu.cn",{"name":283,"role":54,"phone":26,"phoneExt":26,"email":26},"Mian He, MD, PHD",{"name":285,"role":54,"phone":26,"phoneExt":26,"email":26},"Junxiu Liu, MD, PHD",{"facility":287,"status":26,"city":288,"state":289,"zip":290,"country":38,"countryCode":39,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital","Nanning","Guangxi","530000",{"type":41,"coordinates":292},[293,294],108.31667,22.81667,{"lat":294,"lon":293},[297,301],{"name":298,"role":49,"phone":299,"phoneExt":26,"email":300},"Difen Wei","+86-0771-2860539","gxqfybh@163.com",{"name":302,"role":54,"phone":26,"phoneExt":26,"email":26},"Chunqiu Xiong, MD, PHD",{"facility":304,"status":26,"city":288,"state":289,"zip":305,"country":38,"countryCode":39,"cosmosGeoPoint":306,"geoPoint":308,"contacts":309},"The First Affiliated Hospital of Guangxi Medical University","530021",{"type":41,"coordinates":307},[293,294],{"lat":294,"lon":293},[310,314],{"name":311,"role":49,"phone":312,"phoneExt":26,"email":313},"Zhiyi He","+86-0771-5356126","gxmuyfyll@163.com",{"name":315,"role":54,"phone":26,"phoneExt":26,"email":26},"Jiangtao Fan, MD, PhD",{"facility":317,"status":26,"city":318,"state":127,"zip":319,"country":38,"countryCode":39,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Dongguan Maternal and Child Health Care Hosptial","Dongguan","523000",{"type":41,"coordinates":321},[322,323],113.74866,23.01797,{"lat":323,"lon":322},[326,330],{"name":327,"role":49,"phone":328,"phoneExt":26,"email":329},"Caijin Mai","+86-0769-23836146","dgsbjywyh@163.com",{"name":331,"role":54,"phone":26,"phoneExt":26,"email":26},"Ping Zhou, MD, PHD",{"facility":333,"status":26,"city":334,"state":335,"zip":336,"country":38,"countryCode":39,"cosmosGeoPoint":337,"geoPoint":341,"contacts":342},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450052",{"type":41,"coordinates":338},[339,340],113.64861,34.75778,{"lat":340,"lon":339},[343,346],{"name":48,"role":49,"phone":344,"phoneExt":26,"email":345},"0371-66278510","zdyyllwy@163.com",{"name":347,"role":54,"phone":26,"phoneExt":26,"email":26},"Liping Han, MD, PhD",{"facility":349,"status":26,"city":350,"state":351,"zip":352,"country":38,"countryCode":39,"cosmosGeoPoint":353,"geoPoint":357,"contacts":358},"The First Affiliated Hospital with Nanjing Medical University (Jiangsu Provincial People's Hospital)","Nanjing","Jiangsu","210029",{"type":41,"coordinates":354},[355,356],118.77778,32.06167,{"lat":356,"lon":355},[359,362],{"name":48,"role":49,"phone":360,"phoneExt":26,"email":361},"025-68136360","jsphkj@163.com",{"name":363,"role":54,"phone":26,"phoneExt":26,"email":26},"Xiaoling Ma, MD, PhD",{"facility":365,"status":26,"city":366,"state":367,"zip":26,"country":38,"countryCode":39,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"The First Hospital of Jilin University","Changchun","Jinlin",{"type":41,"coordinates":369},[370,371],125.32278,43.88,{"lat":371,"lon":370},[374,378],{"name":375,"role":49,"phone":376,"phoneExt":26,"email":377},"Junqi Niu","+86-0431-88782013","kjkzhaoliyuan@126.com",{"name":379,"role":54,"phone":26,"phoneExt":26,"email":26},"Songling Zhang, MD, PHD",{"facility":381,"status":26,"city":382,"state":383,"zip":384,"country":38,"countryCode":39,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"The General Hospital of Northern Theater Command of the Chinese People's Liberation Army","Shenyang","Liaoning","110016",{"type":41,"coordinates":386},[387,388],123.43278,41.79222,{"lat":388,"lon":387},[391,394],{"name":48,"role":49,"phone":392,"phoneExt":26,"email":393},"024-28851114","btzzyy_irb@163.com",{"name":395,"role":54,"phone":26,"phoneExt":26,"email":26},"Lipeng Pei, MD, PhD",{"facility":397,"status":26,"city":398,"state":399,"zip":400,"country":38,"countryCode":39,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"Shanxi Provincial People's Hospital","Taiyuan","Shanxi","030000",{"type":41,"coordinates":402},[403,404],112.56028,37.86944,{"lat":404,"lon":403},[407,411],{"name":408,"role":49,"phone":409,"phoneExt":26,"email":410},"Xiaoyan Pei","+86-0351-4960060","sxsrmyyllwyh@126.com",{"name":412,"role":54,"phone":26,"phoneExt":26,"email":26},"Yuping Suo, MD, PHD",{"facility":414,"status":26,"city":415,"state":416,"zip":417,"country":38,"countryCode":39,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"The West China Second University Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":41,"coordinates":419},[420,421],104.06667,30.66667,{"lat":421,"lon":420},[424,428],{"name":425,"role":49,"phone":426,"phoneExt":26,"email":427},"Ying Zheng","+86-028-85501685","hx2llwyh@163.com",{"name":429,"role":54,"phone":26,"phoneExt":26,"email":26},"Yuedong He, MD, PHD",{"facility":431,"status":26,"city":432,"state":433,"zip":434,"country":38,"countryCode":39,"cosmosGeoPoint":435,"geoPoint":439,"contacts":440},"Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)","Hangzhou","Zhejiang","310022",{"type":41,"coordinates":436},[437,438],120.16142,30.29365,{"lat":438,"lon":437},[441,444],{"name":48,"role":49,"phone":442,"phoneExt":26,"email":443},"0571-88125287","zjszlyy_irb@163.com",{"name":445,"role":54,"phone":26,"phoneExt":26,"email":26},"Yichen Wang, MD, PhD",{"type":54,"investigatorFullName":447,"investigatorTitle":448,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lu Huaiwu","Professor of Gynecologic Oncology","100643918","phase-2-hexaminolevulinate-photodynamic-therapy-hal-pdt-with-deferred-surgery-versus-surgery-for-high-grade-squamous-intraepithelial-lesions-hsil-100643918",false,"NCT07669363","Hexaminolevulinate Photodynamic Therapy (HAL-PDT) With Deferred Surgery Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)","A Prospective, Open-label, Randomized, Controlled, Non-inferiority Phase II Study Comparing HAL-PDT With Deferred Surgery Versus Immediate Surgery in Subjects With High-grade Squamous Intraepithelial Lesions (HSIL)","Aurora","Inclusion Criteria:\n\n* 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.\n* Able to complete the study in accordance with the study protocol.\n* Subject age ≥18 years.\n* Presence of High-Grade Squamous Intraepithelial Lesion (HSIL) (CIN2 P16 positive\u002FCIN3), specifically: HSIL with histopathological diagnosis of grade II\u002FIII (CIN2 P16 positive\u002FCIN3) within 3 months prior to the first treatment.\n* Adequate colposcopy, including: (a) Complete visibility of the cervical transformation zone, including the squamocolumnar junction; (b) Complete visibility of lesion margins.\n* The investigator determines that non-surgical treatment is acceptable for the participant.\n* The investigator determines that the cervical size is suitable for placement of the HAL-PDT device.\n* 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).\n\nExclusion Criteria:\n\n* Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.\n* CIN2 with P16 negative.\n* Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.\n* 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.\n* The first study treatment day falls within 7 half-lives of the last antiviral medication.\n* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination.\n* Investigator judges that vaginal bleeding during treatment may affect treatment outcomes.\n* 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.\n* 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.\n* History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency.\n* 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.\n* Presence of a cardiac pacemaker.\n* Suspected or known porphyria, or known allergy to the study drug, its chemically similar compounds, or photosensitizers.\n* Allergy to silicone.\n* Pregnant or breastfeeding women.\n* Delivery or miscarriage within 6 weeks prior to enrollment.\n* Participation in any other clinical trial within 30 days prior to study treatment.\n* Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.","FEMALE","18 Days",{"count":460,"type":461},230,"ESTIMATED","INTERVENTIONAL",[464],"PHASE2","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.\n\nThis 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 ).\n\nThe 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.",[467,468],"Cervical Intraepithelial Neoplasia","Papillomavirus Infections",[470,471,472,473,467,474,475,476,477,478,479,480,481],"HSIL","High-Grade Squamous Intraepithelial Lesions","CIN2","CIN3","HAL-PDT","Hexaminolevulinate Photodynamic Therapy","Photodynamic Therapy","LEEP","Cold Knife Conization","Cervical Cancer Prevention","Non-inferiority Trial","HPV Clearance","NOT_YET_RECRUITING","2026-07-08",{"date":485,"type":486},"2026-07-09","ACTUAL",{"date":488,"type":461},"2026-07-01",{"date":490,"type":461},"2029-06-16",{"name":5,"class":6},28]