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]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 90
- 主要终点
- Survival at 1 year
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of telomerase peptide vaccine GV1001 when administered concurrently or sequentially with gemcitabine hydrochloride and capecitabine, in terms of survival, in patients with locally advanced or metastatic pancreatic cancer.
Secondary
- Determine the safety of this regimen in these patients.
- Assess the immunogenicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefit response in patients treated with this regimen.
- Determine the objective response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the survival and response by delayed-type hypersensitivity in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Survival at 1 year
次要结局
- Toxicity as assessed by NCI CTCAE version 3
- Survival and response as assessed by delayed-type hypersensitivity
- Time to progression
- Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life (QLQ) C30 questionnaire and the European Study group for Pancreatic Cancer-QLQ questionnaire
- Clinical benefit response
- Objective response rate as assessed by RECIST criteria