HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2

NCT07634497 | Not Yet Recruiting

• 1 other identifier: WHRWS2601
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Keywords

Hexaminolevulinate Photodynamic Therapy; HAL-PDT; CIN2; HPV; Real-World Study

Outcome Measures

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.

  6 months after the first HAL-PDT session

Secondary Outcomes (4)

• Histopathological regression rate at 12 months

  12 months after the first HAL-PDT session

• HPV clearance rate at 6 months

  6 months after the first HAL-PDT session

• HPV clearance rate at 12 months

  12 months after the first HAL-PDT session

• Safety and tolerability of HAL-PDT

  From informed consent through 12 months after first HAL-PDT session (approximately up to 12 months)

Study Arms (1)

HAL-PDT

All enrolled participants with histologically confirmed CIN2 receive response-guided HAL-PDT. The first two PDT sessions are administered on Day 1 and Day 30-37. At Day 60 (±7 days), colposcopy is performed: participants with complete lesion resolution receive no further PDT (Cohort A, 2 sessions total); those with persistent lesions receive a third PDT at Day 60-67, followed by colposcopy at Day 90. If lesions resolve at Day 90, participants enter follow-up (Cohort B, 3 sessions total); if still persistent, a fourth PDT is given at Day 90-97 (Cohort C, 4 sessions total).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Note: Histopathological diagnosis will be assessed by the pathology department of the participating hospital for enrollment.
• Adequate colposcopy, including:
• Complete visibility of the cervical transformation zone, including the squamocolumnar junction;
• Complete visibility of lesion margins;
• No lesion extension into the cervical canal.
• Cervical size deemed suitable for placement of the HAL-PDT device as assessed by the investigator according to the HAL-PDT package insert.
• 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.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• 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.
• Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years.
• History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency.
• Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment.
• Presence of a cardiac pacemaker.
• Suspected or known porphyria, or known allergy to hexaminolevulinate, its chemically similar compounds, or photosensitizers.
• Allergy to silicone.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics and Gynecology, Peking Union Medical College Hospital

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 15, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06