Cervical Intraepithelial Neoplasia Grade 3Phase 2Lumiteg-INCT07891338
Exploratory Study of the Efficacy of HAL-PDT in CIN 3
A Phase 2 study testing Hexaminolevulinate (HAL) in people with Cervical Intraepithelial Neoplasia Grade 3, run by Tongji Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, biomarker-guided Phase II study evaluating the efficacy and safety of hexaminolevulinate-mediated cervical photodynamic therapy (HAL-PDT) in women with cervical intraepithelial neoplasia grade 3 (CIN3). 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 3
- What is being tested?
- Hexaminolevulinate (HAL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to Dec 2028
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Women aged 18 to 50 years.
- Histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3/HSIL).
- Colposcopy demonstrates a complete transformation zone and the upper margin of the cervical lesion is visible (transformation zone type 1 or 2).
- Positive HPV test at baseline.
- Willing and able to provide written informed consent. These criteria are directly specified in the study protocol.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Known or suspected hypersensitivity to hexaminolevulinate (HAL), related compounds such as aminolevulinic acid (ALA), or any component of the investigational formulation; or a history of porphyria, solar urticaria, or other severe photosensitivity disorders.
- Cervical lesion involving more than 50% of the cervix.
- Acute or active gynecologic infection.
- Current use of an intrauterine device that cannot or will not be removed before initiation of study treatment. For nonmenopausal participants, at least one normal menstrual cycle is recommended after removal to confirm the absence of acute bleeding or infection before enrollment.
- Histologically confirmed or highly suspected invasive cervical cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion.
Show all 22Show fewer
- Concomitant endocervical or vaginal lesions.
- Any cervical treatment within 3 months before enrollment, including but not limited to LEEP, cold knife conization, ablation, cryotherapy, or other local physical or chemical treatment.
- Known severe immunodeficiency, such as active AIDS or uncontrolled autoimmune disease, or ongoing systemic immunosuppressive therapy for 2 weeks or longer, chemotherapy, or other treatment considered by the investigator to substantially affect immune status or interfere with efficacy assessment.
- Any contraindication to the use of the hexaminolevulinate cervical photodynamic therapy system, including:
- invasive cervical cancer, adenocarcinoma in situ, cervical canal intraepithelial neoplasia, or other glandular epithelial lesions;
- a history of toxic shock syndrome;
- porphyria;
- known hypersensitivity to hexaminolevulinate or related aminolevulinate derivatives or any excipient;
- severe gynecologic infection identified by colposcopy or clinical examination;
- menstruation or active vaginal bleeding;
- known silicone allergy;
- presence of a cardiac pacemaker;
- cervical structural abnormality or incomplete cervical anatomy resulting from previous surgery that prevents appropriate use of the disposable cervical photodynamic therapy light device;
- pregnancy or delivery or abortion within the previous 6 weeks.
- Any other condition that, in the investigator's medical judgment, may expose the participant to unacceptable risk or substantially interfere with study data collection or interpretation.
- The exclusion criteria above are based on the protocol's eligibility section.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Nan Yu, +86-02783663636
About this study
Official title: Exploratory Study of the Efficacy of Hexaminolevulinate Hydrochloride Ointment Cervical Photodynamic Therapy System (HAL-PDT）in Cervical Intraepithelial Neoplasia Grade 3
This is a prospective, multicenter, biomarker-guided Phase II study evaluating the efficacy and safety of hexaminolevulinate-mediated cervical photodynamic therapy (HAL-PDT) in women with cervical intraepithelial neoplasia grade 3 (CIN3). Approximately 260 women aged 18 to 50 years with histologically confirmed CIN3 and a positive baseline human papillomavirus (HPV) test will be enrolled.
Participants will receive HAL-PDT using a 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Treatment will be administered once every 2 weeks for a total of 6 treatments.
Read more
The primary objective is to evaluate the overall efficacy of HAL-PDT, measured by the pathological regression rate at 6 months after the first treatment. Pathological regression is defined as biopsy findings showing normal cervical tissue or low-grade squamous intraepithelial lesion (LSIL/CIN1).
The study will also evaluate pathological regression at 12 months, HPV clearance at 3, 6, and 12 months, treatment-related adverse events, changes in cervical lesion characteristics, and the associations between HPV integration status and treatment response. Cervical exfoliated-cell methylation status and p16/Ki-67 dual-stain status will also be assessed during follow-up.
- Being tested
- Hexaminolevulinate (HAL)
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexaminolevulinate (HAL)Combination product
Participants will receive cervical photodynamic therapy with 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Six treatment sessions will be administered at approximately 2-week intervals. The planned treatment period is approximately 10 weeks.
Treatment sessions should preferably be scheduled outside the menstrual period. If a scheduled treatment falls during menstruation, treatment will be postponed until at least 3 days after menstrual bleeding has ended, with subsequent treatment intervals adjusted accordingly.
The investigational treatment system includes a disposable cervical photodynamic therapy light device. The device should be removed from the vagina 11 to 24 hours after insertion.
The treatment parameters will remain consistent across treatment sessions. The protocol specifies 5% hexaminolevulinate ointment and a light fluence of 125 J/cm², with treatment every 2 weeks for six treatments.
| Study group | Role | What they receive |
|---|---|---|
| HAL-PDT | Experimental | Participants will receive hexaminolevulinate-mediated cervical photodynamic therapy using a 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Treatment will be administered once every 2 weeks for a total of 6 treatments Receives: Combination Product: Hexaminolevulinate (HAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Regression Rate at 6 Months
The protocol defines the primary endpoint as the 6-month pathological regression rate, with regression defined as histopathological downgrade to normal cervical tissue or LSIL/CIN1.
Measured: 180 ±14 days after the first HAL-PDT treatment
Secondary outcomes (10)
Colposcopic Lesion Changes at 3 Months
Changes in cervical lesion morphology and lesion extent assessed by colposcopy. No biopsy will be performed at this visit.
Measured: 90 ±7 days after the first HAL-PDT treatment
Pathological Regression Rate at 12 Months
The proportion of participants who achieve pathological regression at the 12-month assessment. Pathological regression is defined as a colposcopy-guided cervical biopsy showing normal cervical tissue or LSIL/CIN1.
Measured: 360 ±30 days after the first HAL-PDT treatment
HPV Clearance Rate at 3 Months
The proportion of participants who become negative for the HPV genotype detected at baseline
Measured: 90 ±7 days after the first HAL-PDT treatment
HPV Clearance Rate at 6 Months
The proportion of participants who become negative for the HPV genotype detected at baseline.
Measured: 180 ±14 days after the first HAL-PDT treatment
HPV Clearance Rate at 12 Months
The proportion of participants who become negative for the HPV genotype detected at baseline.
Measured: 360 ±30 days after the first HAL-PDT treatment
Treatment-Related Adverse Events
Incidence and characteristics of treatment-related adverse events associated with HAL-PDT, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: From the first HAL-PDT treatment through the end of the study
Correlation Between Baseline HPV Integration Status and 6-Month Pathological Response Rate
Baseline HPV integration status will be measured and be categorized as positive or negative, with a semi-quantitative integration level reported. Pathological response is defined as histologic regression to normal cervical tissue or low-grade squamous intraepithelial lesion (LSIL/CIN1) at Month 6 (D180), assessed by colposcopy-directed cervical biopsy with histopathological examination, and is reported as the percentage of participants with response.
Measured: Baseline HPV integration assessment and 180 ±14 days after the first HAL-PDT treatment
Correlation Between Baseline HPV Integration Status and HPV Clearance Rate
Baseline HPV integration status will be measured categorized as positive or negative with a semi-quantitative integration level. HPV clearance is defined as negativity for the baseline HPV genotype(s) at 3, 6 and 12 months after treatment, and is reported as the percentage of participants with clearance.
Measured: Baseline and 3, 6, and 12 months after the first HAL-PDT treatment
Cervical Exfoliated-Cell Gene Methylation Status
Changes in methylation status of selected genes in cervical exfoliated cells. The protocol specifies that genes may include PAX1 and ZNF582.
Measured: 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment
Cervical Exfoliated-Cell p16/Ki-67 Dual-Stain Status
p16/Ki-67 dual-stain status in cervical exfoliated-cell specimens during follow-up.The protocol specifies assessment of cervical exfoliated-cell methylation and p16/Ki-67 dual-stain status at 3 and 6 months.
Measured: 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (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 3Studies of the same condition, open and under way.
- More trials run by Tongji 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Nan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891338
- Sponsor's protocol ID
- TJ-IRB202609063
- Acronym
- Lumiteg-I
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Efficacy of Hexaminolevulinate Hydrochloride Ointment Cervical Photodynamic Therapy System (HAL-PDT）in Cervical Intraepithelial Neoplasia Grade 3
- ClinicalTrials.gov ID
- NCT07891338
- Acronym / sponsor ID
- Lumiteg-I / TJ-IRB202609063
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Oct 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, biomarker-guided Phase II study evaluating the efficacy and safety of hexaminolevulinate-mediated cervical photodynamic therapy (HAL-PDT) in women with cervical intraepithelial neoplasia grade 3 (CIN3). Approximately 260 women aged 18 to 50 years with histologically confirmed CIN3 and a positive baseline human papillomavirus (HPV) test will be enrolled.
Participants will receive HAL-PDT using a 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Treatment will be administered once every 2 weeks for a total of 6 treatments.
The primary objective is to evaluate the overall efficacy of HAL-PDT, measured by the pathological regression rate at 6 months after the first treatment. Pathological regression is defined as biopsy findings showing normal cervical tissue or low-grade squamous intraepithelial lesion (LSIL/CIN1).
The study will also evaluate pathological regression at 12 months, HPV clearance at 3, 6, and 12 months, treatment-related adverse events, changes in cervical lesion characteristics, and the associations between HPV integration status and treatment response. Cervical exfoliated-cell methylation status and p16/Ki-67 dual-stain status will also be assessed during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAL-PDT | Experimental | Combination Product: Hexaminolevulinate (HAL)Participants will receive hexaminolevulinate-mediated cervical photodynamic therapy using a 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Treatment will be administered once every 2 weeks for a total of 6 treatments |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 50 years.
- Histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3/HSIL).
- Colposcopy demonstrates a complete transformation zone and the upper margin of the cervical lesion is visible (transformation zone type 1 or 2).
- Positive HPV test at baseline.
- Willing and able to provide written informed consent. These criteria are directly specified in the study protocol.
Key exclusion criteria (22 listed)
- Known or suspected hypersensitivity to hexaminolevulinate (HAL), related compounds such as aminolevulinic acid (ALA), or any component of the investigational formulation; or a history of porphyria, solar urticaria, or other severe photosensitivity disorders.
- Cervical lesion involving more than 50% of the cervix.
- Acute or active gynecologic infection.
- Current use of an intrauterine device that cannot or will not be removed before initiation of study treatment. For nonmenopausal participants, at least one normal menstrual cycle is recommended after removal to confirm the absence of acute bleeding or infection before enrollment.
- Histologically confirmed or highly suspected invasive cervical cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion.
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 |
|---|---|---|
| Hexaminolevulinate (HAL)Participants will receive cervical photodynamic therapy with 5% hexaminolevulinate ointment and a light fluence of 125 J/cm². Six treatment sessions will be administered at approximately 2-week intervals. The planned treatment period is approximately 10 weeks. Treatment sessions should preferably be scheduled outside the menstrual period. If a scheduled treatment falls during menstruation, treatment will be postponed until at least 3 days after menstrual bleeding has ended, with subsequent treatment intervals adjusted accordingly. The investigational treatment system includes a disposable cervical photodynamic therapy light device. The device should be removed from the vagina 11 to 24 hours after insertion. The treatment parameters will remain consistent across treatment sessions. The protocol specifies 5% hexaminolevulinate ointment and a light fluence of 125 J/cm², with treatment every 2 weeks for six treatments. | Combination product | HAL-PDT |
Primary outcome
Pathological Regression Rate at 6 Months
Time frame: 180 ±14 days after the first HAL-PDT treatment
The protocol defines the primary endpoint as the 6-month pathological regression rate, with regression defined as histopathological downgrade to normal cervical tissue or LSIL/CIN1.
10 secondary outcomes
Colposcopic Lesion Changes at 3 Months
Time frame: 90 ±7 days after the first HAL-PDT treatment
Pathological Regression Rate at 12 Months
Time frame: 360 ±30 days after the first HAL-PDT treatment
HPV Clearance Rate at 3 Months
Time frame: 90 ±7 days after the first HAL-PDT treatment
HPV Clearance Rate at 6 Months
Time frame: 180 ±14 days after the first HAL-PDT treatment
HPV Clearance Rate at 12 Months
Time frame: 360 ±30 days after the first HAL-PDT treatment
Treatment-Related Adverse Events
Time frame: From the first HAL-PDT treatment through the end of the study
Correlation Between Baseline HPV Integration Status and 6-Month Pathological Response Rate
Time frame: Baseline HPV integration assessment and 180 ±14 days after the first HAL-PDT treatment
Correlation Between Baseline HPV Integration Status and HPV Clearance Rate
Time frame: Baseline and 3, 6, and 12 months after the first HAL-PDT treatment
Cervical Exfoliated-Cell Gene Methylation Status
Time frame: 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment
Cervical Exfoliated-Cell p16/Ki-67 Dual-Stain Status
Time frame: 90 ±7 days and 180 ±14 days after the first HAL-PDT 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 23 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hexaminolevulinate (HAL) in people with Cervical Intraepithelial Neoplasia Grade 3, run by Tongji Hospital at 1 site 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 6 inclusion and 22 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 23 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 1 site 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?
Contact Nan Yu (+86-027-83663636, nny86@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Regression Rate at 6 Months (time frame: 180 ±14 days after the first HAL-PDT 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 23 Oct 2026.