A phase I clinical trial to assess the efficacy of treatment with SIR-Spheres microspheres in patients with liver metastases from primary cancer of the pancreas

Sirtex Medical Limited0 个研究点目标入组 10 人开始时间: 2006年1月10日最近更新: 2020年1月13日

试验速览

暂无简介。

•Pancreatic adenocarcinoma with contrast CT evidence of measurable liver metastases. Liver metastases should be the dominant site of disease and must be considered as impacting on patient QoL and/or survivalBaseline imaging must be <29 days of trial entry. Suitable for treatmentLife expectancy of at least 2 months without active treatmentPrior treatment of liver metastases is not allowed.Adequate Hematological, hepatic and renal function.WHO performance status 0-1.Willing and able to provide written informed consent.Female patients must be postmenopausal, sterile or using an acceptable method of contraception.

•Evidence of ascites, cirrhosis or portal hypertension as determined by clinical and radiological assessment.Occlusion of the main portal vein.Central nervous system metastases as determined by CT or MRI scan.Previous radiotherapy to the upper abdomen that included the liver in the treatment field.Evidence of any concurrent condition that would render the patient ineligible for treatment according to the protocol.Hepatic arterial anatomy that would prevent the administration of SIR-Spheres into the liver.>20% arteriovenous lung shunting on a technetium99 - MAA nuclear scan.Female patients who are pregnant or breastfeeding.Participation in a clinical trial of an investigational agent within 30 days of SIRT.

发起方