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Not yet recruiting NCT07306260

Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2

No phase Interventional HSIL, High Grade Squamous Intraepithelial Lesion CIN 2 HPV (Human Papillomavirus)-Associated Photodynamic Therapy (PDT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALA-PDT, LEEP surgery.
Who it may be relevant to
Registry conditions: HSIL, High Grade Squamous Intraepithelial Lesion, CIN 2, HPV (Human Papillomavirus)-Associated, Photodynamic Therapy (PDT). Basic parameters: 25 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.

Interventions

  • Procedure ALA-PDT
    Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
  • Procedure LEEP surgery
    After anesthesia, cervical iodine staining was performed, followed by LEEP.

Primary outcome measures

  • Lesion effective rate [Time frame: 6 months]
Secondary outcome measures (3)
  • Lesion effective rate [Time frame: 2 years]
  • HPV clearance rate [Time frame: 2 years]
  • Lesion cure rate [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • Women's Hospital School Of Medicine Zhejiang University — Hangzhou
  • First People's Hospital of Hangzhou — Hangzhou
  • Hangzhou Linping District first People's Hospital — Hangzhou
  • First Affiliated Hospital of Ningbo University — Ningbo
  • Shaoxing People's Hospital — Shaoxing

Identifiers

NCT: NCT07306260 · 2025-1382

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗