HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult females aged 18-50 years with newly diagnosed, histologically confirmed CIN2 within 3 months prior to first treatment. Participants must have adequate colposcopy: complete visibility of the transformation zone and lesion margins, no endocervical extension. Cervical size must be suitable for HAL-PDT device placement. Exclusion criteria include prior surgical or physical therapy for CIN2, pregnancy/lactation, active STDs, known porphyria or allergies to study materials, and participation in another trial within 30 days.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: HAL-PDT
Trial outcomes
Primary outcomes
1
Histopathological regression rate at 6 months
Proportion of participants with histopathological downgrading from cervical intraepithelial neoplasia grade 2 (CIN2) to normal or low-grade squamous intraepithelial lesion (LSIL/CIN1) on colposcopy-directed cervical biopsy, assessed at 6 months after the first HAL-PDT treatment.
Time frame
6 months after the first HAL-PDT sessionSecondary outcomes
1
Histopathological regression rate at 12 months
Proportion of participants with histopathological downgrading from cervical intraepithelial neoplasia grade 2 (CIN2) to normal or low-grade squamous intraepithelial lesion (LSIL/CIN1) on colposcopy-directed cervical biopsy, assessed at 12 months after the first HAL-PDT treatment.
Time frame
12 months after the first HAL-PDT session2
HPV clearance rate at 6 months
Proportion of participants with clearance of high-risk human papillomavirus (HPV) subtypes (including but not limited to HPV 16, 18, 52, 58) assessed at 6 months after the first HAL-PDT treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype that was present at baseline.
Time frame
6 months after the first HAL-PDT session3
HPV clearance rate at 12 months
Proportion of participants with clearance of high-risk human papillomavirus (HPV) subtypes (including but not limited to HPV 16, 18, 52, 58) assessed at 12 months after the first HAL-PDT treatment. HPV clearance is defined as undetectable of the same high-risk HPV subtype that was present at baseline.
Time frame
12 months after the first HAL-PDT session4
Safety and tolerability of HAL-PDT
Incidence, type, severity (mild, moderate, severe), duration, and relatedness to study treatment of adverse events (AEs) and serious adverse events (SAEs) occurring from signing of informed consent through the end of study follow-up.
Time frame
From informed consent through 12 months after first HAL-PDT session (approximately up to 12 months)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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