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临床试验/NL-OMON54345
NL-OMON54345尚未招募2 期

Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil* device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study - PANCOSI

Amsterdam UMC, locatie AMC0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
20

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

  • - Age >=18 years
  • - Locally advanced pancreatic cancer, defined by the DPCG consensus criteria
  • as: arterial involvement >90* or venous involvement >270*.
  • - At least RECIST stable disease after a minimum two months of chemotherapy
  • according to current clinical practice*
  • - Capable of providing written and oral informed consent
  • - Candidate for RNT, judged by a multidisciplinary tumor board
  • - WHO 0-2
  • * FOLFIRINOX for patients with WHO 0-1 performance status and
  • gemcitabine-nab-paclitaxel for patients with > 1-2performance status.

排除标准

  • - Eligibility for resection
  • - Participation in other trials focussing on different ablative treatment
  • modalities such as radiofrequency ablation or irreversible electroporation for
  • - Bleeding disorders which cannot be corrected with medication
  • - Inability/unwillingness to interrupt anticoagulation therapy
  • - Pregnancy
  • - Metastatic pancreatic cancer
  • - Epilepsy episode(s) in the past six months
  • - Longest tumor diameter >70 mm or total target tumor volume >110 ml
  • - Presence of multiple collateral vessels surrounding or adjacent to the target
  • tumor on radiologic imagining, prohibiting safe injection of the OncosilTM
  • - Presence (or significant risk) of varices near the target tumor on radiologic
  • - Recent clinically significant pancreatitis
  • - Previous administration of radiotherapy to the pancreas
  • - WHO > 2

研究者

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