JPRN-jRCT2041190087已完成2 期
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:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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
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