ACTRN12606000007538
进行中(未招募)
1 期
A phase 1/2 study to test the safety and efficacy of a single implantation of SIR-Spheres plus systemic chemotherapy with FOLFOX4 in patients with liver metastases derived from colorectal carcinoma.
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- nresectable liver metastases from colorectal carcinoma
- 发起方
- Sirtex Medical Limited
- 入组人数
- 20
- 状态
- 进行中(未招募)
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Histologically confirmed adenocarcinoma of the colon or rectum. CT evidence of malignant metastases in the liver. Liver metastases not treatable by some other form of local ablation. Prior treatment for metastatic CRC is not allowedAdequate hepatic, renal and haematological functionWHO performance status 0\-2Willing and able to provide written informed consent.
排除标准
- •Pregnant or breast feedingEvidence of ascites, cirrhosis or portal hypertensionCNS metastases Previous radiotherapy to the upper abdomenNon\-malignant disease that would render the patient ineligible for treatmentEquivocal, immeasurable or unevaluable metastases in the liverHepatic arterial anatomy that would prevent administration of SIR\-Spheres\>20% arteriovenous lungshuntingDLT associated with previous 5FU chemotherapy.
结局指标
主要结局
未指定
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