Clinical trial NCT06439433: ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase IIc Clinical Trial of ALA-PDT in Patients With Cervical Intraepithelial Neoplasia Grade 2 (CIN2) in p16-positivity and High-risk HPV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia Grade 2
Papillomavirus Infections
p16 Protein
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

Detailed description: A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

Eligibility criteria: Inclusion Criteria:

* Premenopausal women, 18-45 years of age
* Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
* Intense desire to retain the cervical structure or function
* High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
* Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
* Signed written informed consent

Exclusion Criteria:

* Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
* Invasive carcinoma possibility or lesions extending to the vaginal wall
* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
* Undiagnosed vaginal bleeding within the last 3 months
* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
* With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN)
* History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
* Pregnancy or nursing
* Participation in any clinical studies within the last 30 days
* Poor compliance or inability to complete the trial
* Subjects that the investigators judged to be not suitable to participate the study besides above

Primary outcomes:
measure: Response rate at week 12 after last treatment
timeFrame: Baseline and week 12 after treatments
Secondary outcomes:
measure: Response rate at week 24 after last treatment
timeFrame: Baseline and week 24 after treatments
measure: Cure rate at week 12 after last treatment
timeFrame: Baseline and week 12 after treatments
measure: Cure response rate at week 24 after last treatment
timeFrame: Baseline and week 24 after treatments
measure: Clearance rate of HPV at week 12 after last treatment
timeFrame: Baseline and week 12 after treatments
measure: Clearance rate of HPV at week 24 after last treatment
timeFrame: Baseline and week 24 after treatments
Other outcomes:
measure: Response rate of HPV16 and/or HPV18 positive patients at week 12 after last treatment
timeFrame: Baseline and week 12 after treatments
measure: Response rate of HPV16 and/or HPV18 positive patients at week 24 after last treatment
timeFrame: Baseline and week 24 after treatments
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: The Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: