EUCTR2004-003990-10-DE进行中（未招募）不适用
Multicenter, open-label, randomized, controlled phase III clinical study of the efficacy and safety of photodynamic therapy using porfimer sodium for injection as palliative treatment for unresectable cholangiocarcinoma - Not available
Axcan Pharma Inc.0 个研究点目标入组 166 人开始时间: 2005年5月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible for this study, patients must meet all of the following criteria:
- •1. Patients are males or females aged 18 or older.
- •2. Confirmation of the primary diagnosis by central assessors.
- •3. Non-menopausal or non-surgically sterilized female patients must have a negative serum beta–HCG at the time of entry into the study and use a medically acceptable form of birth control.
- •4. Patients must sign an Informed Consent Form, which must comply with the ICH guidelines and local requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with any of the following conditions must be excluded from this trial:
- •1. Patients who have previously received PDT for cholangiocarcinoma.
- •2. Patients with known porphyria or known hypersensitivity to porphyrins.
- •3. Patients who have received chemotherapy, brachytherapy, or radiotherapy during the 90 days prior to randomization.
- •4. Patients who have previously undergone metal stent insertion.
- •5. Patients who have previously undergone surgical resection of the cholangiocarcinoma.
- •6. Patients with any acute or chronic medical or psychological illnesses as judged clinically significant by the investigator to preclude PDT procedure.
- •7. Patients with current untreated primary diagnosis of anxiety or depression according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM IV).
- •8. Patients with a presence or history of neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin.
- •9. Patients who score less than 30% on the Karnofsky Performance Scale Index.
- •10. Patients with a white blood cell (WBC) count < 2.0 x 10^9/L, platelet count < 50 x 10^9/L, hemoglobin < 90 g/L, hematocrit < 27%, prothrombin time (PT) expressed as the international normalized ratio (INR) > 2 times the upper limit of normal (ULN) uncorrectable with vitamin K.
- •11. Patients with decompensated cirrhosis.
- •12. Patients who have been treated with any investigational drug during 60 days prior to the screening visit.
- •13. Patients who are unable or unwilling to complete the follow-up evaluations required for the study.
研究者
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