EUCTR2004-003990-10-GB进行中（未招募）1 期
Multicenter, open-label, randomised, controlled phase III clinical study of the efficacy and safety of photodynamic therapy using porfimer sodium for injection as palliative treatment for unresectable cholangiocarcinoma
Axcan Pharma Inc. (Axcan Pharma International B.V. is a subsidiary of Axcan Pharma Inc.)0 个研究点目标入组 166 人开始时间: 2005年2月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 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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