ISRCTN43482138已完成3 期
A prospective, phase III, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capecitabine therapy with concurent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer
The University of Liverpool (UK)0 个研究点目标入组 1,062 人开始时间: 2005年12月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,062
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24954781 results
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Aged over 18 years
- •2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma
- •3. Locally advanced or metastatic disease precluding curative surgical resection
- •4. Contrast enhanced Computed Tomography (CT) scan of the thorax, abdomen and pelvis within 28 days of randomisation
- •5. Unidimensionally measurable disease (CT) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
- •6. World Health Organisation (WHO) performance status zero, one or two
- •7. Platelets more than 100 x 10^9/l; white blood cell count (WBC) more than 3 x 10^9/l; neutrophils more than 1.5 x 10^9/l at entry
- •8. Serum bilirubin less than 35 µmol/l
- •9. Calculated creatinine clearance over 50 ml/min
- •10. No concurrent uncontrolled medical condition
- •11. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
- •12. Life expectancy more than three months
- •13. Adequate contraceptive precautions if relevant
- •14. Informed written consent
排除标准
- •1. Medical or psychiatric conditions compromising informed consent
- •2. Intracerebral metastases or meningeal carcinomatosis
- •3. Clinically significant serious disease or organ system disease not currently controlled on present therapy
- •4. Uncontrolled angina pectoris
- •5. Pregnancy or breast feeding
- •6. Treatment with chemotherapy, radiotherapy or other investigational drug within the last four weeks prior to inclusion
- •7. Known malabsorption syndromes
- •8. Patients with a known hypersensitivity to Fluorouracil (5-FU) or with a Dihydropyrimidine Dehydrogenase (DPD) deficiency
- •9. Immunosuppressive therapy less than four weeks prior to the start of treatment
- •10. People of child-bearing potential unless effective methods of contraception are used
研究者
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