ACTRN12617000030370进行中（未招募）3 期
Individual Patient Data Prospective Meta-analysis (IPD PMA) of Selective Internal Radiation Therapy (SIRT) versus Sorafenib for Locally Advanced or Recurrent Hepatocellular Carcinoma (HCC) Including SARAH and SIRveNIB Trials
ational Cancer Centre Singapore0 个研究点目标入组 819 人开始时间: 2017年1月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 819
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •*Adults (older than or equal to 18 years of age) with a life expectancy of over 3 months.
- •*Histologic or cytologic diagnosis or AASLD criteria for the diagnosis of HCC and at least one measurable lesion on CT according to RECIST criteria
- •*Written consent.
- •*Patients with advanced HCC according to the Barcelona criteria (stage C), with or without portal invasion, and who are not eligible for surgical resection, liver transplantation or radiofrequency (ablation) OR patients with recurrent HCC (new
- •location) or patients with chemoembolisation failure.
- •*ECOG performance status lesser or equal to 1.
- •*Liver cirrhosis Child-Pugh A - B7.
- •SIRveNIB only:
- •Adequate haematological, renal and hepatic function as follows*:
- •Leukocytes greater or equal to 2,500/µL
- •Platelets greater or equal to 80,000/µL
- •Haemoglobin greater than 9.5 g/dL
- •Total bilirubin lesser than 2.0 mg/dL
- •INR lesser or equal to 2.0
- •ALPlesser or equal to 5 x institutional upper limit of normal
- •AST and ALT lesser or equal to 5 x institutional upper limit of normal
- •Albumin greater or equal to 2.5 g/dL
- •Creatinine lesser or equal to 2.0 mg/dL
- •*Suitable for protocol treatment as determined by clinical assessment undertaken by the Investigator.
- •SARAH only:
- •*Neutrophils greater or equal to 1500/mm3.
- •*Platelets greater or equal to 50000/mm3.
- •*Haemoglobin greater or equal to 9 g/100 mL.
- •*Bilirubin lesser or equal to 50 µmol/L.
- •*INR lesser or equal to 1.5.
- •*AST or ALT lesser or equal to 5 x ULN.
- •*Adequate kidney function, creatinine lesser 150 µmol.
- •*Patient affiliated to social security scheme or beneficiary.
排除标准
- •*Advanced Liver disease with A Child-Pugh score > B7 or active digestive haemorrhage or encephalopathy or refractory ascites.
- •*Patient unable or unwilling to comply with the treatment and follow-up required by the trial.
- •*Previously treated advanced HCC (excluding chemoembolisation).
- •*Contraindication to hepatic artery catheterisation such as severe peripheral arterial disease precluding catheterisation.
- •*Allergy to contrast agents.
- •*Pregnant or breastfeeding women.
- •*Mental illness or Other psychological disorder affecting the informed consent.
- •SARAH only:
- •*Patient unable to take oral medication.
- •*Extrahepatic metastases (including pulmonary tumours > 1 cm and lymph node tumours > 2 cm).
- •*Other primary tumour except for basal-cell carcinomas or superficial bladder cancers.
- •SIRveNIB only:
- •*Complete obstruction of the main portal vein.
- •*Extrahepatic metastases except patients with small lung nodules or lymph nodes.
- •*Portal hypertension with hepatofugal flow as documented on baseline spiral CT scan.
- •*Male patients must be surgically sterile, or if sexually active and having a pre-menopausal female partner then must be using an acceptable form of contraception.
研究者
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