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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

Other trials in China

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 groups in NCT07669363
Study groupRoleWhat they receive
Hexaminolevulinate Photodynamic Therapy (HAL-PDT) with Deferred SurgeryExperimentalSubjects 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 SurgeryActive comparatorParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted25 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion16 Jun 2029 (estimated)
  4. Study completion16 Jun 2029 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT07669363.

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.

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