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

NCT07891338 | Not Yet Recruiting Phase 2

• 1 other identifier: TJ-IRB202609063
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Intraepithelial Neoplasia Grade 3

Outcome Measures

Primary Outcomes (1)

• 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.

  180 ±14 days after the first HAL-PDT treatment

Secondary Outcomes (10)

• Colposcopic Lesion Changes at 3 Months

  90 ±7 days after the first HAL-PDT treatment

• Pathological Regression Rate at 12 Months

  360 ±30 days after the first HAL-PDT treatment

• HPV Clearance Rate at 3 Months

  90 ±7 days after the first HAL-PDT treatment

• HPV Clearance Rate at 6 Months

  180 ±14 days after the first HAL-PDT treatment

• HPV Clearance Rate at 12 Months

  360 ±30 days after the first HAL-PDT treatment

Study Arms (1)

HAL-PDT

EXPERIMENTAL

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)

Interventions

Hexaminolevulinate (HAL) COMBINATION_PRODUCT

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.

HAL-PDT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria:
• Women aged 18 to 50 years.
• Histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3/HSIL).
• Colposcopy demonstrates a complete transformation zone and the upper margin of the cervical lesion is visible (transformation zone type 1 or 2).
• Positive HPV test at baseline.
• Willing and able to provide written informed consent. These criteria are directly specified in the study protocol.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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.
• Cervical lesion involving more than 50% of the cervix.
• Acute or active gynecologic infection.
• 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.
• Histologically confirmed or highly suspected invasive cervical cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion.
• Concomitant endocervical or vaginal lesions.
• 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.
• 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.
• 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;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Nan Yu

CONTACT

+86-027-83663636; nny86@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)