Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405CIN for patients with cervical intraepithlial neoplasia

Murakami Hirotake0 个研究点目标入组 75 人开始时间: 2019年11月26日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Female patients over 20 years old when obtaining consent
•2)The subjects were patients who were diagnosed with CIN2 or CIN3 based on cervical cytology and histology findings and whose lesions were confirmed macroscopically by colposcopy.
•3) Patients who do not wish to receive treatment other than PDT including
•4) Eastern Cooperative Oncology Group performance status; 0-1
•5) Patients with adequate bone marrow function
•1.White blood cell count ; >3,000/mm3
•2.Platelet count ; >100,000/mm3
•3.Both alanine aminotransferase and aspartate aminotransferase ; Less than twice the facility standard
•4.Serum total bilirubin level ; <2.0 mg/dL
•5.Blood urea nitrogen and serum creatinine; Less than 1.5 times the facility standard
•6) Provision of written informed consent.

•1) patients with AGC (atypical glandular cells), AIS (adenocarcinoma in situ), invasive squamous cell carcinoma or other cervical malignant tumor
•2) patients diagnosed with UCF (Unsatisfactory colposcopic findings) or TZ type3 by colposcopy
•3) patients with other cancer
•4) significant cardiovascular diseases (uncontrolled hypertension, myocardial infarction, unstable angina, congestive heart failure), uncontrolled diabetes mellitus, or severe liver cirrhosis, severe renal failure
•5) preexisting of sun photosensitivity
•6) porphyria
•7) history of treatment with PDT using porfimer sodium or talaporfin sodium
•8) pregnant or nursed women, and woman want to pregnancy within this trial period
•9) unwillingness to use of contraception
•10) participating in other clinical trials or within 3 months after retirement of prior clinical trial
•11) judged by investigator that enrollment was inappropriate for the patient

发起方

Murakami Hirotake