HPV-16/18ALA-PDT-LSILNCT07306247
Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection
A study testing ALA-PDT in people with HPV-16/18 and Photodynamic Therapy (PDT), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-16/18, Photodynamic Therapy (PDT), LSIL, Low Grade Squamous Intraepithelial Lesion
- What is being tested?
- ALA-PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesChina
- Study dates
- 21 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 20-60 years, understands study procedures and consents to participate;
- HPV 16 or 18 positive;
- Colposcopy-guided cervical biopsy within 3 months showing LSIL;
- 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.
Jianwei Zhou, Professor contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
Ying Li, Doctor, 13705815380, 17550215@qq.com
- Not yet recruiting
First People's Hospital of Hangzhou
Hangzhou, Zhejiang
Hongkai Shang, Doctor, 15990032799
- Not yet recruiting
Hangzhou Linping District first People's Hospital
Hangzhou, Zhejiang
Lifang You, Doctor, 18958174527, y20042668@sina.com
- Not yet recruiting
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 310000
Juanjuan Shi, Doctor, 138 8449 6502, bessalice0707@163.com
- Not yet recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang, 310000
Huaqin Pang, 13625757126, hqpang@163.com
About this study
Official title: Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical Low-grade Squamous Intraepithelial Lesions With HPV16/18 Infection
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Read the detailed description
This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.
- Being tested
- ALA-PDT
- Keywords
- cervical low-grade squamous intraepithelial lesions, aminolevulinic acid-mediated photodynamic therapy, efficacy, human papillomavirus
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA-PDTProcedure or surgery
Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
| Study group | Role | What they receive |
|---|---|---|
| ALA-PDT Group | Experimental | ALA-PDT administered every 7-14 days for a total of 3-6 sessions. Receives: Procedure: ALA-PDT |
| Observation Group | No intervention | Observation and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical lesion regression rate
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
Measured: 6 months
Secondary outcomes (2)
HPV clearance rate
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
Measured: 2 years
Cervical lesion regression rate
Proportion of patients with normal colposcopy-guided cervical biopsy histopathology, or NILM cytology plus negative HPV test, at 12 and 24 months.
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 start21 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HPV-16/18Studies 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
- 225 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306247
- Sponsor's protocol ID
- 2025-1380
- Acronym
- ALA-PDT-LSIL
- Status last verified
- Oct 2026
- First submitted
- 14 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li D, Wang Z, Liu Y, Zhou M, Xia B, Zhang L, Chen K, Zeng Y. Assessing the risk of high-grade squamous intraepithelial lesions (HSIL+) in women with LSIL biopsies: a machine learning-based study. Infect Agent Cancer. 2024 Dec 5;19(1):61. doi: 10.1186/s13027-024-00625-z.
PubMed 39639322Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.1016/j.pdpdt.2022.102807. Epub 2022 Mar 11.
PubMed 35288319Qiu L, Li J, Chen F, Wang Y, Wang Y, Wang X, Lv Q, Li C, Li M, Yang Q, Wu D, Zhang Y, Zhang Y, Zhang M, Zhang Y, Qie M, Zhou H, Zhou J, Zhao W, Xia B, Liang X, Cai Y, Teng Y, Huang Z, Sui L, Wei L, Di W. Chinese expert consensus on the clinical applications of aminolevulinic acid-based photodynamic therapy in female lower genital tract diseases (2022). Photodiagnosis Photodyn Ther. 2022 Sep;39:102993. doi: 10.1016/j.pdpdt.2022.102993. Epub 2022 Jul 1.
PubMed 35781093Wang X, Xu X, Ma Y, Tang Y, Huang Z. Comparative Study of 5-Aminolevulinic Acid-Mediated Photodynamic Therapy and the Loop Electrosurgical Excision Procedure for the Treatment of Cervical High-Grade Squamous Intraepithelial Lesions. Pharmaceutics. 2024 May 20;16(5):686. doi: 10.3390/pharmaceutics16050686.
PubMed 38794347Persson M, Elfstrom KM, Olsson SE, Dillner J, Andersson S. Minor Cytological Abnormalities and up to 7-Year Risk for Subsequent High-Grade Lesions by HPV Type. PLoS One. 2015 Jun 17;10(6):e0127444. doi: 10.1371/journal.pone.0127444. eCollection 2015.
PubMed 26083247Kusakabe M, Taguchi A, Sone K, Mori M, Osuga Y. Carcinogenesis and management of human papillomavirus-associated cervical cancer. Int J Clin Oncol. 2023 Aug;28(8):965-974. doi: 10.1007/s10147-023-02337-7. Epub 2023 Jun 9.
PubMed 37294390Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 16 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 Low-grade Squamous Intraepithelial Lesions With HPV16/18 Infection
- ClinicalTrials.gov ID
- NCT07306247
- Acronym / sponsor ID
- ALA-PDT-LSIL / 2025-1380
- Keywords
- cervical low-grade squamous intraepithelial lesions, aminolevulinic acid-mediated photodynamic therapy, efficacy, human papillomavirus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 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
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Jan 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 multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Detailed description
This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.
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 administered every 7-14 days for a total of 3-6 sessions. |
| Observation Group | No intervention | –Observation and follow-up |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, 20-60 years, understands study procedures and consents to participate;
- HPV 16 or 18 positive;
- Colposcopy-guided cervical biopsy within 3 months showing LSIL;
- 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-PDTPhotosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions. | Procedure or surgery | ALA-PDT Group |
Primary outcome
Cervical lesion regression rate
Time frame: 6 months
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
2 secondary outcomes
HPV clearance rate
Time frame: 2 years
Cervical lesion regression 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 16 Oct 2026.
- Results publication: PubMed 39639322Li D, Wang Z, Liu Y, Zhou M, Xia B, Zhang L, Chen K, Zeng Y. Assessing the risk of high-grade squamous intraepithelial lesions (HSIL+) in women with LSIL biopsies: a machine learning-based study. Infect Agent Cancer. 2024 Dec 5;19(1):61. doi: 10.1186/s13027-024-00625-z.
- Results publication: PubMed 35288319Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.1016/j.pdpdt.2022.102807. Epub 2022 Mar 11.
- Results publication: PubMed 35781093Qiu L, Li J, Chen F, Wang Y, Wang Y, Wang X, Lv Q, Li C, Li M, Yang Q, Wu D, Zhang Y, Zhang Y, Zhang M, Zhang Y, Qie M, Zhou H, Zhou J, Zhao W, Xia B, Liang X, Cai Y, Teng Y, Huang Z, Sui L, Wei L, Di W. Chinese expert consensus on the clinical applications of aminolevulinic acid-based photodynamic therapy in female lower genital tract diseases (2022). Photodiagnosis Photodyn Ther. 2022 Sep;39:102993. doi: 10.1016/j.pdpdt.2022.102993. Epub 2022 Jul 1.
- Results publication: PubMed 38794347Wang X, Xu X, Ma Y, Tang Y, Huang Z. Comparative Study of 5-Aminolevulinic Acid-Mediated Photodynamic Therapy and the Loop Electrosurgical Excision Procedure for the Treatment of Cervical High-Grade Squamous Intraepithelial Lesions. Pharmaceutics. 2024 May 20;16(5):686. doi: 10.3390/pharmaceutics16050686.
- Results publication: PubMed 26083247Persson M, Elfstrom KM, Olsson SE, Dillner J, Andersson S. Minor Cytological Abnormalities and up to 7-Year Risk for Subsequent High-Grade Lesions by HPV Type. PLoS One. 2015 Jun 17;10(6):e0127444. doi: 10.1371/journal.pone.0127444. eCollection 2015.
- Results publication: PubMed 37294390Kusakabe M, Taguchi A, Sone K, Mori M, Osuga Y. Carcinogenesis and management of human papillomavirus-associated cervical cancer. Int J Clin Oncol. 2023 Aug;28(8):965-974. doi: 10.1007/s10147-023-02337-7. Epub 2023 Jun 9.
- Results publication: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- 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.
Jianwei Zhou, Professor contact
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 in people with HPV-16/18 and Photodynamic Therapy (PDT), 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 4 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 16 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 (+86 0571-87783759, doctorwangxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical lesion regression 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?
On the ClinicalTrials.gov record for NCT07306247, which also lists 7 linked publications.
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 Oct 2026.