NL-OMON55025招募中不适用
Irreversible electroporation and Nivolumab combined with intratumoral administration of a toll like receptor ligand as a means of in vivo vaccination for metastatic pancreatic cancer - PANFIRE III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Radiological and histopathologically proven stage IV pancreatic cancer
- •(according to the AJCC staging system for pancreatic cancer)
- •- Primary metastatic disease, defined as at least 1 bioptable metastasis.
- •- Maximum of 5 unequivocal metasases of 1cm or larger may be present at the
- •time of inclusion (i.e., after chemotherapy).
- •- Primary tumor is in situ.
- •- A minimum of 4 cycles of FOLFIRINOX chemotherapy is required but with the
- •explicit aim to strive for completion of 8 cycles of FOLFIRINOX before study
- •inclusion, with at least stable disease on CTscan.
- •- A recovery periodof 4-6 weeks after final administration of FOLIRINOX is
- •- Age >= 18 years.
- •- World Health Organisation scale (WHO) performance status 0 - 2;
- •- Adequate bile drainage in case of biliary obstruction.
排除标准
- •- Brain metastasis
- •- Active epilepsy (last convulsion < 5 years);
- •- History of cardiac disease:Congestive heart failure > NYHA Class 2
- •- Active autoimmune disease requiring disease-modifying therapy at the time of
- •screening: i.e. > 10 mg prednisolone per day or equivalent to this regimen.
- •- Previous surgical therapy for pancreatic cancer
- •- Any implanted stimulation device
- •- Portal vein or VMS stenosis > 70%, or any arterial stenosis (AMS, celiac
- •artery, common hepatic artery) > 70%
研究者
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