NCT07306260

Brief Summary

This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 14, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 14, 2025

Last Update Submit

December 14, 2025

Conditions

CIN 2HPV (Human Papillomavirus)-AssociatedPhotodynamic Therapy (PDT)HSIL, High Grade Squamous Intraepithelial Lesion

Keywords

photodynamic therapyHigh Grade Squamous Intraepithelial Lesionhuman papillomavirusloop electrosurgical excision procedureefficacy

Outcome Measures

Primary Outcomes (1)

  • Lesion effective rate

    Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.

    6 months

Secondary Outcomes (3)

  • Lesion effective rate

    2 years

  • HPV clearance rate

    2 years

  • Lesion cure rate

    2 years

Other Outcomes (2)

  • Impact on cervical anatomy and function

    2 years

  • Adverse events

    2 years

Study Arms (2)

ALA-PDT Group

EXPERIMENTAL

ALA-PDT treatment for cervical lesions 6 to 9 times

Procedure: ALA-PDT

LEEP Group

ACTIVE COMPARATOR

LEEP surgery for cervical lesions

Procedure: LEEP surgery

Interventions

ALA-PDTPROCEDURE

Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.

ALA-PDT Group
LEEP surgeryPROCEDURE

After anesthesia, cervical iodine staining was performed, followed by LEEP.

LEEP Group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, 25-60 years, understands study procedures and consents to participate;
  • Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
  • Provides written informed consent.

You may not qualify if:

  • Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
  • Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
  • Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
  • Undiagnosed vaginal bleeding;
  • Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
  • Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
  • Pregnant or breastfeeding women;
  • History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);
  • Use of interferon or antiviral therapy within 3 months;
  • Any other condition deemed unsuitable for participation by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Location

Hangzhou Linping District first People's Hospital

Hangzhou, Zhejiang, China

Location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

Shaoxing People's Hospital

Shaoxing, Zhejiang, China

Location

MeSH Terms

Conditions

Squamous Intraepithelial LesionsPapillomavirus Infections

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic Processes

Central Study Contacts

Xiaoyun Wang, Doctor

CONTACT

15168479997doctorwangxy@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2025

First Posted

December 29, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)