EUCTR2011-003601-25-GR进行中（未招募）1 期
Randomised, Multicenter Phase III Clinical Study of Lipoplatin plus Gemcitabine Versus Gemcitabine as First-Line Treatment in Inoperable, Locally Advanced or Metastatic Pancreatic Cancer
Regulon AE0 个研究点目标入组 328 人开始时间: 2012年2月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 328
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
- •Adult male or female > 18 years of age; histologically or cytologically confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma; at least one measurable lesion; no prior chemotherapy/ radiotherapy/other investigational drug treatment for pancreatic cancer; performance status 0-2; life expectancy >3 months; adequate haematologic/hepatic/renal/cardiac function; signed informed consent.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •oOther malignancy within the past 5 years, except malignancies with <5% probability of recurrence, curatively treated squamous or basal cell skin carcinoma, or in situ carcinoma of the cervix.
- •oKnown allergy to any of the study drug components.
- •oPrior chemotherapy, radiotherapy or investigational drug treatment for pancreatic cancer.
- •oKnown brain metastases.
- •oRecent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias.
- •oKnown Hepatitis B or C, or AIDS.
- •oKnown underlying immune deficiency or history of autoimmune diseases (e.g. autoimmune neutropenia, hemolytic anaemia or thrombocytopenia, systemic lupus erythematosus, Sjögren syndrome, Addison’s disease, scleroderma, myasthenia Gravis, Goodpasture’s syndrome).
- •oPregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement.
- •oAny medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia).
- •oPatients for whom compliance with the protocol is doubtful
研究者
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