Cervical Intraepithelial Neoplasia Grade 2 (CIN2)NCT07634497
HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
An observational study of Cervical Intraepithelial Neoplasia Grade 2 (CIN2), run by Peking Union Medical College Hospital.
Trial summary
This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2 (CIN2)
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Dec 2029
- Phase
- Observational
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Adult females aged 18-50 years with newly diagnosed, histologically confirmed CIN2 within 3 months prior to first treatment. Participants must have adequate colposcopy: complete visibility of the transformation zone and lesion margins, no endocervical extension. Cervical size must be suitable for HAL-PDT device placement. Exclusion criteria include prior surgical or physical therapy for CIN2, pregnancy/lactation, active STDs, known porphyria or allergies to study materials, and participation in another trial within 30 days.
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.
- Female aged ≥18 years and ≤50 years.
- Newly diagnosed High-Grade Squamous Intraepithelial Lesion (HSIL), cervical intraepithelial neoplasia grade 2 (CIN2) within 3 months, specifically: CIN2 confirmed by tissue biopsy within 3 months prior to the first treatment.
- Note: Histopathological diagnosis will be assessed by the pathology department of the participating hospital for enrollment.
- Adequate colposcopy, including:
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- Complete visibility of the cervical transformation zone, including the squamocolumnar junction;
- Complete visibility of lesion margins;
- No lesion extension into the cervical canal.
- Cervical size deemed suitable for placement of the HAL-PDT device as assessed by the investigator according to the HAL-PDT package insert.
- Meets the following conditions: negative pregnancy test; 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.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.
- Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.
- Prior treatment (surgical or physical therapy) for the condition, or receipt of physical or surgical therapy within 3 months after the current histopathological diagnosis of CIN2.
- The date of the first HAL-PDT treatment falls within 7 half-lives of the last antiviral medication.
- History of toxic shock syndrome.
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- 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 hexaminolevulinate, 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 HAL-PDT treatment.
- Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.
About this study
Official title: A Prospective, Multicenter Real-world Study of HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.
Read the detailed description
BACKGROUND:
Cervical intraepithelial neoplasia grade 2 (CIN2) is a high-grade precancerous lesion with a variable natural history. Current management options include active surveillance or local ablation/excision, but there is interest in minimally invasive treatments that preserve cervical integrity. Hexaminolevulinate photodynamic therapy (HAL-PDT) uses a photosensitizer that accumulates in dysplastic cells and, upon activation by red light, induces targeted cell death while potentially stimulating local anti-HPV immunity.
STUDY DESIGN RATIONALE:
This prospective, multicenter real-world study is designed to assess the effectiveness and safety of HAL-PDT in routine clinical practice. Unlike a traditional randomized controlled trial, this study uses an adaptive treatment regimen guided by colposcopic response at predefined time points. Participants receive an initial two PDT sessions, and additional sessions (up to a total of four) are given if lesions persist on colposcopy. This response-adaptive approach mirrors clinical decision-making and allows evaluation of a tailored treatment strategy.
DETAILED PROCEDURES:
- Index date: Day 1 (first PDT).
- PDT sessions: Day 1, Day 30-37 (mandatory for all). Additional PDT at Day 60-67 (if lesions present at D60 colposcopy) and/or at Day 90-97 (if lesions persist after third PDT).
- Colposcopy with biopsy for histopathology is performed at baseline (within 3 months pre-enrollment), at Month 6 (±7 days), and at Month 12 (±7 days). HPV genotyping and TCT are performed at screening, Month 3 (only for those receiving additional PDT), Month 6, and Month 12.
- Adverse events are collected from informed consent through the 12-month follow-up.
STATISTICAL METHODS:
The primary analysis will estimate the histopathological regression rate at 6 months with a two-sided 95% confidence interval using the exact binomial method. Secondary endpoints (regression at 12 months, HPV clearance at 6 and 12 months) will be analyzed similarly. Subgroup analyses by number of PDT sessions (2, 3, or 4) are exploratory. No formal hypothesis testing against an external control is planned. Safety data will be summarized descriptively.
SAMPLE SIZE CONSIDERATIONS:
A total of 500 participants will be enrolled.
- Keywords
- Hexaminolevulinate Photodynamic Therapy, HAL-PDT, CIN2, HPV, Real-World Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HAL-PDT | All enrolled participants with histologically confirmed CIN2 receive response-guided HAL-PDT. The first two PDT sessions are administered on Day 1 and Day 30-37. At Day 60 (±7 days), colposcopy is performed: participants with complete lesion resolution receive no further PDT (Cohort A, 2 sessions total); those with persistent lesions receive a third PDT at Day 60-67, followed by colposcopy at Day 90. If lesions resolve at Day 90, participants enter follow-up (Cohort B, 3 sessions total); if still persistent, a fourth PDT is given at Day 90-97 (Cohort C, 4 sessions total). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological regression rate at 6 months
Proportion of participants with histopathological downgrading from cervical intraepithelial neoplasia grade 2 (CIN2) to normal or low-grade squamous intraepithelial lesion (LSIL/CIN1) on colposcopy-directed cervical biopsy, assessed at 6 months after the first HAL-PDT treatment.
Measured: 6 months after the first HAL-PDT session
Secondary outcomes (4)
Histopathological regression rate at 12 months
Proportion of participants with histopathological downgrading from cervical intraepithelial neoplasia grade 2 (CIN2) to normal or low-grade squamous intraepithelial lesion (LSIL/CIN1) on colposcopy-directed cervical biopsy, assessed at 12 months after the first HAL-PDT treatment.
Measured: 12 months after the first HAL-PDT session
HPV clearance rate at 6 months
Proportion of participants with clearance of high-risk human papillomavirus (HPV) subtypes (including but not limited to HPV 16, 18, 52, 58) assessed at 6 months after the first HAL-PDT treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype that was present at baseline.
Measured: 6 months after the first HAL-PDT session
HPV clearance rate at 12 months
Proportion of participants with clearance of high-risk human papillomavirus (HPV) subtypes (including but not limited to HPV 16, 18, 52, 58) assessed at 12 months after the first HAL-PDT treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype that was present at baseline.
Measured: 12 months after the first HAL-PDT session
Safety and tolerability of HAL-PDT
Incidence, type, severity (mild, moderate, severe), duration, and relatedness to study 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 first HAL-PDT session (approximately up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Dec 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 Neoplasia Grade 2 (CIN2)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Chen, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634497
- Sponsor's protocol ID
- WHRWS2601
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Real-world Study of HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
- ClinicalTrials.gov ID
- NCT07634497
- Acronym / sponsor ID
- WHRWS2601
- Keywords
- Hexaminolevulinate Photodynamic Therapy, HAL-PDT, CIN2, HPV, Real-World Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 8 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.
This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.
Detailed description
BACKGROUND:
Cervical intraepithelial neoplasia grade 2 (CIN2) is a high-grade precancerous lesion with a variable natural history. Current management options include active surveillance or local ablation/excision, but there is interest in minimally invasive treatments that preserve cervical integrity. Hexaminolevulinate photodynamic therapy (HAL-PDT) uses a photosensitizer that accumulates in dysplastic cells and, upon activation by red light, induces targeted cell death while potentially stimulating local anti-HPV immunity.
STUDY DESIGN RATIONALE:
This prospective, multicenter real-world study is designed to assess the effectiveness and safety of HAL-PDT in routine clinical practice. Unlike a traditional randomized controlled trial, this study uses an adaptive treatment regimen guided by colposcopic response at predefined time points. Participants receive an initial two PDT sessions, and additional sessions (up to a total of four) are given if lesions persist on colposcopy. This response-adaptive approach mirrors clinical decision-making and allows evaluation of a tailored treatment strategy.
DETAILED PROCEDURES:
- Index date: Day 1 (first PDT).
- PDT sessions: Day 1, Day 30-37 (mandatory for all). Additional PDT at Day 60-67 (if lesions present at D60 colposcopy) and/or at Day 90-97 (if lesions persist after third PDT).
- Colposcopy with biopsy for histopathology is performed at baseline (within 3 months pre-enrollment), at Month 6 (±7 days), and at Month 12 (±7 days). HPV genotyping and TCT are performed at screening, Month 3 (only for those receiving additional PDT), Month 6, and Month 12.
- Adverse events are collected from informed consent through the 12-month follow-up.
STATISTICAL METHODS:
The primary analysis will estimate the histopathological regression rate at 6 months with a two-sided 95% confidence interval using the exact binomial method. Secondary endpoints (regression at 12 months, HPV clearance at 6 and 12 months) will be analyzed similarly. Subgroup analyses by number of PDT sessions (2, 3, or 4) are exploratory. No formal hypothesis testing against an external control is planned. Safety data will be summarized descriptively.
SAMPLE SIZE CONSIDERATIONS:
A total of 500 participants will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAL-PDT | – | –All enrolled participants with histologically confirmed CIN2 receive response-guided HAL-PDT. The first two PDT sessions are administered on Day 1 and Day 30-37. At Day 60 (±7 days), colposcopy is performed: participants with complete lesion resolution receive no further PDT (Cohort A, 2 sessions total); those with persistent lesions receive a third PDT at Day 60-67, followed by colposcopy at Day 90. If lesions resolve at Day 90, participants enter follow-up (Cohort B, 3 sessions total); if still persistent, a fourth PDT is given at Day 90-97 (Cohort C, 4 sessions total). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult females aged 18-50 years with newly diagnosed, histologically confirmed CIN2 within 3 months prior to first treatment. Participants must have adequate colposcopy: complete visibility of the transformation zone and lesion margins, no endocervical extension. Cervical size must be suitable for HAL-PDT device placement. Exclusion criteria include prior surgical or physical therapy for CIN2, pregnancy/lactation, active STDs, known porphyria or allergies to study materials, and participation in another trial within 30 days.
Key inclusion criteria (11 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.
- Female aged ≥18 years and ≤50 years.
- Newly diagnosed High-Grade Squamous Intraepithelial Lesion (HSIL), cervical intraepithelial neoplasia grade 2 (CIN2) within 3 months, specifically: CIN2 confirmed by tissue biopsy within 3 months prior to the first treatment.
- Note: Histopathological diagnosis will be assessed by the pathology department of the participating hospital for enrollment.
Key exclusion criteria (19 listed)
- Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.
- Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.
- Prior treatment (surgical or physical therapy) for the condition, or receipt of physical or surgical therapy within 3 months after the current histopathological diagnosis of CIN2.
- The date of the first HAL-PDT treatment falls within 7 half-lives of the last antiviral medication.
- History of toxic shock syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histopathological regression rate at 6 months
Time frame: 6 months after the first HAL-PDT session
Proportion of participants with histopathological downgrading from cervical intraepithelial neoplasia grade 2 (CIN2) to normal or low-grade squamous intraepithelial lesion (LSIL/CIN1) on colposcopy-directed cervical biopsy, assessed at 6 months after the first HAL-PDT treatment.
4 secondary outcomes
Histopathological regression rate at 12 months
Time frame: 12 months after the first HAL-PDT session
HPV clearance rate at 6 months
Time frame: 6 months after the first HAL-PDT session
HPV clearance rate at 12 months
Time frame: 12 months after the first HAL-PDT session
Safety and tolerability of HAL-PDT
Time frame: From informed consent through 12 months after first HAL-PDT session (approximately up to 12 months)
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 16 Jun 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 record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia Grade 2 (CIN2), run by Peking Union Medical College Hospital.
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 11 inclusion and 19 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological regression rate at 6 months (time frame: 6 months after the first HAL-PDT session). 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 16 Jun 2026.