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临床试验/NCT04146441
NCT04146441已完成2 期

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年2月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Volume change of primary tumor

研究概览

简要总结

Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors.

In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
  • eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
  • ECOG 0 - 1

排除标准

  • Known contraindications for SonoVue
  • Hematological bleeding status before experimental treatment:
  • Hb < 8g/dL, trc < 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
  • Pregnancy

研究组 & 干预措施

control

Active Comparator

chemotherapy

干预措施: Chemotherapy (Drug)

SonoVue

Experimental

SonoVue + chemotherapy

干预措施: SonoVue (Combination Product)

SonoVue

Experimental

SonoVue + chemotherapy

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Volume change of primary tumor

时间窗: 8 weeks

measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment

次要结局

  • Rate of reported toxicity(8 weeks)
  • Number of down-staged tumors from stage III to stage II(1 year)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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