EUCTR2006-000461-10-GB进行中（未招募）1 期
A prospective, phase III, controlled, multicentre, randomised clinical trial comparing combination gemcitabine and capecitabine therapy with concurrent and sequential chemoimmunotherapy using a telomerase vaccine in locally advanced and metastatic pancreatic cancer. - TeloVac
The Royal Liverpool University Hospital NHS Trust0 个研究点目标入组 1,062 人开始时间: 2006年7月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,062
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
入选标准
- •1. Age > 18 years. 2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas. 3. Locally advanced or metastatic disease precluding curative surgical resection. 4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment. 5. Unidimensionally measurable disease (CT) in accordance with the RECIST guidelines. 6. ECOG performance status 0, 1 or 2. 7. Platelets >100 x 109/l; WBC > 3 x 109/l; neutrophils > 1.5 x 109/l at entry. 8.Serum Bilirubin <35 micromol/l 9. Calculated creatinine clearance over 50ml/min according to Cockcroft & Gault. 10. Life expectancy > 3 months. 11. Informed written 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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. Previous chemotherapy. 7. Radiotherapy within the last 4 weeks prior to start of study treatment. 8. Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated Basal Cell Carcinoma of the skin or in situ carcinoma of the uterine cervix 9. Known malabsorption syndromes. 10. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency. 11. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms. 12. Chemotherapy directed at tumour apart from that described in this protocol. 13. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
研究者
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