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NCT07891338

PHASE2

Exploratory Study of the Efficacy of HAL-PDT in CIN 3

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

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). 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.

Official title: Exploratory Study of the Efficacy of Hexaminolevulinate Hydrochloride Ointment Cervical Photodynamic Therapy System (HAL-PDT）in Cervical Intraepithelial Neoplasia Grade 3

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-11

Completion Date

2028-12

Last Updated

2026-10-23

Healthy Volunteers

Conditions

Cervical Intraepithelial Neoplasia Grade 3

Interventions

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.

Inclusion Criteria: Participants must meet all of the following criteria: 1. Women aged 18 to 50 years. 2. Histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3/HSIL). 3. Colposcopy demonstrates a complete transformation zone and the upper margin of the cervical lesion is visible (transformation zone type 1 or 2). 4. Positive HPV test at baseline. 5. Willing and able to provide written informed consent. These criteria are directly specified in the study protocol. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. 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. 2. Cervical lesion involving more than 50% of the cervix. 3. Acute or active gynecologic infection. 4. 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. 5. Histologically confirmed or highly suspected invasive cervical cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion. 6. Concomitant endocervical or vaginal lesions. 7. 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. 8. 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. 9. 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. 10. 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.

Locations (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China