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: 2022年8月15日

适应症

试验速览

•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

•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

发起方

The University of Liverpool (UK)