A Phase 2 interventional study of Hexaminolevulinate (HAL) in Cervical Intraepithelial Neoplasia Grade 3, sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Tongji Hospital · Phase 2, Interventional, and Treatment
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.
367 studies on the registry are indexed under Uterine Cervical Dysplasia; 70 are open to participants now.
This study's planned enrollment of 260 is above the median of 166 across 253 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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;
The exclusion criteria above are based on the protocol's eligibility section.
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
Combination Product: 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.
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.
Time frame: 180 ±14 days after the first HAL-PDT treatment
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 90 ±7 days and 180 ±14 days after the first HAL-PDT treatment
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Hexaminolevulinate hydrochloride