HSIL, High Grade Squamous Intraepithelial LesionPDT for CIN2NCT07306260
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
A study testing ALA-PDT and LEEP surgery in people with HSIL, High Grade Squamous Intraepithelial Lesion and CIN 2, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2, HPV (Human Papillomavirus)-Associated
- What is being tested?
- ALA-PDT and LEEP surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 5 sitesChina
- Study dates
- 29 Jan 2026to Dec 2027
- Phase
- Interventional
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, 25-60 years, understands study procedures and consents to participate;
- Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
- Provides written informed consent.
Who cannot join
- Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
- Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
- Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
- Undiagnosed vaginal bleeding;
- Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
- Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
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- Pregnant or breastfeeding women;
- History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);
- Use of interferon or antiviral therapy within 3 months;
- Any other condition deemed unsuitable for participation by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Ying Li, 13705815380, 17550215@qq.com
- Not yet recruiting
First People's Hospital of Hangzhou
Hangzhou, Zhejiang
Hongkai Shang, Doctor, 15990032799, 806520681@qq.com
- Recruiting
Hangzhou Linping District first People's Hospital
Hangzhou, Zhejiang
Lifang You, 18958174527, y20042668@sina.com
y20042668@sina.com
- Not yet recruiting
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Juanjuan Shi, 138 8449 6502, bessalice0707@163.com
- Not yet recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang
Huaqin Pang, 13625757126, hqpang@163.com
hqpang@163.com
About this study
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
Read the detailed description
This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2, HPV (Human Papillomavirus)-Associated, Photodynamic Therapy (PDT)
- Being tested
- ALA-PDT, LEEP surgery
- Keywords
- photodynamic therapy, High Grade Squamous Intraepithelial Lesion, human papillomavirus, loop electrosurgical excision procedure, efficacy
- Medical subject headings
- Squamous Intraepithelial Lesions, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA-PDTProcedure or surgery
Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
LEEP surgeryProcedure or surgery
After anesthesia, cervical iodine staining was performed, followed by LEEP.
| Study group | Role | What they receive |
|---|---|---|
| ALA-PDT Group | Experimental | ALA-PDT treatment for cervical lesions 6 to 9 times Receives: Procedure: ALA-PDT |
| LEEP Group | Active comparator | LEEP surgery for cervical lesions Receives: Procedure: LEEP surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion effective rate
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
Measured: 6 months
Secondary outcomes (3)
Lesion effective rate
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment.
Measured: 2 years
HPV clearance rate
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
Measured: 2 years
Lesion cure rate
Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start29 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSIL, High Grade Squamous Intraepithelial LesionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, First People's Hospital of Hangzhou, First Affiliated Hospital of Ningbo University, Shaoxing People's Hospital, Linping First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306260
- Sponsor's protocol ID
- 2025-1382
- Acronym
- PDT for CIN2
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
- ClinicalTrials.gov ID
- NCT07306260
- Acronym / sponsor ID
- PDT for CIN2 / 2025-1382
- Conditions
- HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2, HPV (Human Papillomavirus)-Associated, Photodynamic Therapy (PDT)
- Keywords
- photodynamic therapy, High Grade Squamous Intraepithelial Lesion, human papillomavirus, loop electrosurgical excision procedure, efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University, First People's Hospital of Hangzhou, First Affiliated Hospital of Ningbo University, Shaoxing People's Hospital, Linping First People's Hospital
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (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 study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
Detailed description
This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA-PDT Group | Experimental | Procedure: ALA-PDTALA-PDT treatment for cervical lesions 6 to 9 times |
| LEEP Group | Active comparator | Procedure: LEEP surgeryLEEP surgery for cervical lesions |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female, 25-60 years, understands study procedures and consents to participate;
- Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
- Provides written informed consent.
Key exclusion criteria (10 listed)
- Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
- Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
- Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
- Undiagnosed vaginal bleeding;
- Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
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 |
|---|---|---|
| ALA-PDTApply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions. | Procedure or surgery | ALA-PDT Group |
| LEEP surgeryAfter anesthesia, cervical iodine staining was performed, followed by LEEP. | Procedure or surgery | LEEP Group |
Primary outcome
Lesion effective rate
Time frame: 6 months
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
3 secondary outcomes
Lesion effective rate
Time frame: 2 years
HPV clearance rate
Time frame: 2 years
Lesion cure rate
Time frame: 2 years
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALA-PDT and LEEP surgery in people with HSIL, High Grade Squamous Intraepithelial Lesion and CIN 2, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Contact Xiaoyun Wang, Doctor (15168479997, doctorwangxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion effective rate (time frame: 6 months). 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 14 Oct 2026.