HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
500 participantsStarted 2026-06-15
Plain-language 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). 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Adequate colposcopy, including:
. Cervical size deemed suitable for placement of the HAL-PDT device as assessed by the investigator according to the HAL-PDT package insert.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Histopathological regression rate at 6 months
Timeframe: 6 months after the first HAL-PDT session
. 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.
Exclusion criteria
. 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.
. 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.