Cervical Intraepithelial NeoplasiaPhase 2AuroraNCT07669363
Hexaminolevulinate Photodynamic Therapy (HAL-PDT) With Deferred Surgery Versus Surgery for High-grade Squamous Intraepithelial Lesions (HSIL)
A Phase 2 study testing Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC) and HAL 5% with illumination in people with Cervical Intraepithelial Neoplasia and Papillomavirus Infections, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 days and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Papillomavirus Infections
- What is being tested?
- Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC) and HAL 5% with illumination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 28 sitesChina
- Study dates
- 1 Jul 2026to 16 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 days and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites
The First Hospital of Jilin University
Changchun, Jinlin
Junqi Niu, +86-0431-88782013, kjkzhaoliyuan@126.com
Songling Zhang, MD, PHD
The West China Second University Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ying Zheng, +86-028-85501685, hx2llwyh@163.com
Yuedong He, MD, PHD
Dongguan Maternal and Child Health Care Hosptial
Dongguan, Guangzhou, 523000
Caijin Mai, +86-0769-23836146, dgsbjywyh@163.com
Ping Zhou, MD, PHD
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Xiaolian Wu, +86-0757-83163871, fsllwyh@fsyyy.com
Lijiang Xu, MD, PHD
Foshan Shunde Maternal and Child Health Hospital
Foshan, Guangdong, 528300
Shilin Cao, +86-0757-22976967, 783902092@qq.com
Jinzhi Huang, MD, PHD
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Ethics Committee Administrator, 0591-83357896, fjxhe_irb@163.com
Dezhao Chen, MD, PhD
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Ethics Committee Administrator, 0591-87982001, fdyy_irb@163.com
Lihong Chen, MD, PhD
Guangdong Women and Children Hospital
Guangzhou, Guangdong, 510010
Aihua Yin, +86-020-39151890, gdsfyec@163.com
Xiaoli Sun, MD, PHD
The Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Ethics Committee Administrator, 020-83509159, gydyzlyy_irb@163.com
Bin Wen, MD, PhD
Guangdong ProvincialHospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Administrator Ethics Committee, 020-81887233-35943, Ilbgs@gzucm.edu.cn
Jing Xiao, MD, PhD
Guangzhou First People's Hospital (The Second Affiliated Hospital of South China University of Technology)
Guangzhou, Guangdong, 510180
Ethics Committee Administrator, 020-81045412, MEC_GZSY@126.com
Yan Kuang, MD, PhD
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510280
Ethics Office Administrator, +86-020-62783372, zjyygcp@163.com
Xuefeng Wang, MD, PhD
Guangdong Second Provincial GeneralHospital (Guangdong Provincial Emergency Hospital)
Guangzhou, Guangdong, 510317
Administrator Clinical Research Office, +86-20-89168338, gdech_irb@163.com
Xiafei Fu, MD, PhD
The First AffiliatedHospital, Guangzhou University ofTraditional Chinese Medicine
Guangzhou, Guangdong, 510405
Ethics Committee Administrator, +86-20-36588667, gztcmlunli@163.com
Sijin Li, MD, PhD
Guangzhou Women and Children's Medical Center (The Affiliated Women and Children's Medical Center of Guangzhou Medical University)
Guangzhou, Guangdong, 510623
Ethics Committee Administrator, 020-81886332, gzwc_irb@163.com
Kun Shi, MD, PhD
Panyu Central Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 511400
Ethics Committee Administrator, 020-34858888, pyzxylunli@163.com
Xiang Yang, MD, PhD
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310022
Ethics Committee Administrator, 0571-88125287, zjszlyy_irb@163.com
Yichen Wang, MD, PhD
The First Affiliated Hospital with Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing, Jiangsu, 210029
Ethics Committee Administrator, 025-68136360, jsphkj@163.com
Xiaoling Ma, MD, PhD
Guangxi Zhuang Autonomous Region Maternal and Child Health Hospital
Nanning, Guangxi, 530000
Difen Wei, +86-0771-2860539, gxqfybh@163.com
Chunqiu Xiong, MD, PHD
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhiyi He, +86-0771-5356126, gxmuyfyll@163.com
Jiangtao Fan, MD, PhD
The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, Liaoning, 110016
Ethics Committee Administrator, 024-28851114, btzzyy_irb@163.com
Lipeng Pei, MD, PhD
Shenzhen Maternity and Child Health Hospital
Shenzhen, Guangdong, 518031
Liu, +86-0755-83579801, szfygcpll@163.com
Ping Jin, MD, PHD
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Ethics Committee Administrator, 0755-83923333, pkuszh_irb@163.com
Zhihong Liu, MD, PhD
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000
Xiaoyan Pei, +86-0351-4960060, sxsrmyyllwyh@126.com
Yuping Suo, MD, PHD
Xiamen Maternity and Child Healthcare Hospital
Xiamen, Fujian, 361001
Ethics Committee Administrator, 0592-2662920, xmfyllwyh@163.com
Qing Li, MD, PHD
he First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Jiajie Lin, +86-0592-2137569, xdfyec@163.com
Qionghua Chen, MD, PHD
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Ethics Committee Administrator, 0371-66278510, zdyyllwy@163.com
Liping Han, MD, PhD
The First Affiliated Hospital, Sun Yat-sen University
Zhongshan, Guangdong, 510080
Ying Lin, +86-020-87330631（FAX）, zsyyiec2020@mail.sysu.edu.cn
Mian He, MD, PHD
About this study
Official title: 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)
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.
Read the detailed description
High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are well-established precursors to invasive cervical cancer. Immediate excisional procedures such as loop electrosurgical excision procedure (LEEP) or cold knife conization remain the standard of care; however, they are associated with significant long-term morbidities, including cervical stenosis, cervical incompetence, and adverse obstetric outcomes in women of childbearing age. Hexaminolevulinate photodynamic therapy (HAL-PDT) is a non-invasive, tissue-preserving modality that offers a potential alternative.
This Phase II trial is designed to test the hypothesis that HAL-PDT (HAL-PDT Q2W×6 ) with deferred surgery achieves a 12-month pathological regression rate non-inferior to that of immediate surgery, while providing a favorable safety and quality-of-life profile.
A total of 230 subjects are planned for enrollment, with 115 allocated to each treatment arm. The primary efficacy analysis will be performed on both the Intention-to-Treat (ITT) and Per-Protocol (PP) populations to test the non-inferiority margin, which is pre-specified based on clinically acceptable thresholds. Safety analyses will be conducted on the Safety Set (SS).
- Being tested
- Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC), HAL 5% with illumination
- Keywords
- HSIL, High-Grade Squamous Intraepithelial Lesions, CIN2, CIN3, Cervical Intraepithelial Neoplasia, HAL-PDT, Hexaminolevulinate Photodynamic Therapy, Photodynamic Therapy, LEEP, Cold Knife Conization, Cervical Cancer Prevention, Non-inferiority Trial, HPV Clearance
- Medical subject headings
- Uterine Cervical Dysplasia, Papillomavirus Infections, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC)Procedure or surgery
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 illuminationCombination product
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: HAL 5% with illumination |
| Immediate Surgery | Active comparator | Participants with histologically confirmed HSIL (CIN2 P16 positive/CIN3) 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. Receives: Procedure: Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological regression rate at 12 months
Proportion of participants with pathological remission on colposcopy-directed cervical biopsy at 12 months after the first treatment. Pathological remission is defined as histopathological finding of normal tissue or low-grade squamous intraepithelial lesion (LSIL)
Measured: 12 months after the first treatment
Secondary outcomes (6)
Human Papillomavirus (HPV) baseline clearance rate at 6 months
Proportion of participants with clearance of baseline high-risk Human Papillomavirus (HPV) subtypes at 6 months after the first treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype(s) that were present at baseline.
Measured: 6 months after the first treatment
Pathological remission rate at 6 months
Proportion of participants with pathological remission on colposcopy-directed cervical biopsy at 6 months after the first treatment. Pathological remission is defined as histopathological finding of normal tissue or low-grade squamous intraepithelial lesion (LSIL).
Measured: 6 months after the first treatment
HPV baseline clearance rate at 12 months
Proportion of participants with clearance of baseline high-risk HPV subtypes at 12 months after the first treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype(s) that were present at baseline.
Measured: 12 months after the first treatment
Quality of life assessed by EORTC QLQ-CX24
Quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Cervical Cancer Module (EORTC QLQ-CX24). Scores for each domain are linearly transformed to a 0-100 scale. For global health status and functional domains, a higher score indicates a better outcome (better quality of life/function). For symptom scales, a higher score indicates a worse outcome (more severe symptoms).
Measured: 12 months after the first treatment
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence, type, severity (mild, moderate, severe), duration, and relatedness to photodynamic therapy and/or surgical treatment of adverse events (AEs) and serious adverse events (SAEs) occurring from signing of informed consent through the end of study follow-up.
Measured: From informed consent through 12 months after the first treatment
Incidence of cervical cancer at 12 months
Proportion of participants with histologically confirmed cervical cancer (any stage) diagnosed within 12 months after the first treatment.
Measured: 12 months after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion16 Jun 2029 (estimated)
- Study completion16 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Huaiwu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669363
- Sponsor's protocol ID
- SYSKY-2026-336-03
- Acronym
- Aurora
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07669363
- Acronym / sponsor ID
- Aurora / SYSKY-2026-336-03
- Keywords
- HSIL, High-Grade Squamous Intraepithelial Lesions, CIN2, CIN3, Cervical Intraepithelial Neoplasia, HAL-PDT, Hexaminolevulinate Photodynamic Therapy, Photodynamic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 16 Jun 2029 (estimated)
- Study completion
- 16 Jun 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High-grade squamous intraepithelial lesions (HSIL), encompassing cervical intraepithelial neoplasia grade 2 (CIN2) with p16 positivity and grade 3 (CIN3), are well-established precursors to invasive cervical cancer. Immediate excisional procedures such as loop electrosurgical excision procedure (LEEP) or cold knife conization remain the standard of care; however, they are associated with significant long-term morbidities, including cervical stenosis, cervical incompetence, and adverse obstetric outcomes in women of childbearing age. Hexaminolevulinate photodynamic therapy (HAL-PDT) is a non-invasive, tissue-preserving modality that offers a potential alternative.
This Phase II trial is designed to test the hypothesis that HAL-PDT (HAL-PDT Q2W×6 ) with deferred surgery achieves a 12-month pathological regression rate non-inferior to that of immediate surgery, while providing a favorable safety and quality-of-life profile.
A total of 230 subjects are planned for enrollment, with 115 allocated to each treatment arm. The primary efficacy analysis will be performed on both the Intention-to-Treat (ITT) and Per-Protocol (PP) populations to test the non-inferiority margin, which is pre-specified based on clinically acceptable thresholds. Safety analyses will be conducted on the Safety Set (SS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hexaminolevulinate Photodynamic Therapy (HAL-PDT) with Deferred Surgery | Experimental | Combination Product: HAL 5% with illuminationSubjects 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. |
| Immediate Surgery | Active comparator | Procedure: Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC)Participants with histologically confirmed HSIL (CIN2 P16 positive/CIN3) 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. |
Who may qualify
- Ages
- 18 days and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Immediate Surgery |
| HAL 5% with illuminationHAL-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). | Combination product | Hexaminolevulinate Photodynamic Therapy (HAL-PDT) with Deferred Surgery |
Primary outcome
Histopathological regression rate at 12 months
Time frame: 12 months after the first treatment
Proportion of participants with pathological remission on colposcopy-directed cervical biopsy at 12 months after the first treatment. Pathological remission is defined as histopathological finding of normal tissue or low-grade squamous intraepithelial lesion (LSIL)
6 secondary outcomes
Human Papillomavirus (HPV) baseline clearance rate at 6 months
Time frame: 6 months after the first treatment
Pathological remission rate at 6 months
Time frame: 6 months after the first treatment
HPV baseline clearance rate at 12 months
Time frame: 12 months after the first treatment
Quality of life assessed by EORTC QLQ-CX24
Time frame: 12 months after the first treatment
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: From informed consent through 12 months after the first treatment
Incidence of cervical cancer at 12 months
Time frame: 12 months after the first treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loop Electrosurgical Excision Procedure (LEEP) or Cold Knife Conization (CKC) and HAL 5% with illumination in people with Cervical Intraepithelial Neoplasia and Papillomavirus Infections, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological regression rate at 12 months (time frame: 12 months after the first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.