ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection
- Conditions
- Cervical Intraepithelial Neoplasia Grade 2Papillomavirus Infectionsp16 Protein
- Interventions
- Drug: PlaceboDrug: Aminolaevulinic acid (500-mg bottle)Drug: Aminolaevulinic acid (750-mg bottle)
- Registration Number
- NCT06439433
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 119
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Group ALA A Group Aminolaevulinic acid (500-mg bottle) ALA 500mg Group ALA B Group Aminolaevulinic acid (750-mg bottle) ALA 750mg Group
- Primary Outcome Measures
Name Time Method Response rate at week 12 after last treatment Baseline and week 12 after treatments "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
- Secondary Outcome Measures
Name Time Method Clearance rate of HPV at week 12 after last treatment Baseline and week 12 after treatments Proportion of patients with HPV clearance
Response rate at week 24 after last treatment Baseline and week 24 after treatments "Response" is defined as: pathology showed normal or only inflammatory changes or CIN1
Cure rate at week 12 after last treatment Baseline and week 12 after treatments "Cure" is defined as: pathology showed normal or only inflammatory changes
Cure response rate at week 24 after last treatment Baseline and week 24 after treatments "Cure" is defined as: pathology showed normal or only inflammatory changes
Clearance rate of HPV at week 24 after last treatment Baseline and week 24 after treatments Proportion of patients with HPV clearance
Trial Locations
- Locations (5)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China